Entrants, exits, funding, launches, recalls — internal hemorrhoids office based treatment

1. Summary

The office-based hemorrhoid device landscape traces to a single 1997 predicate ligator and has since grown mostly by acquisition rather than by durable new-firm entry: the bipolar RF ligator line originated by HET Systems, LLC and the Barrx anorectal RF wand both ended up on the books of Covidien, and then Medtronic, within roughly a decade of their original clearances [1][6][9]. A parallel stapled-hemorrhoidopexy device class shows the opposite pattern — its two most recent US clearances, in 2019 and 2021, both belong to Chinese manufacturers entering a decade after the original 2009 US clearance holder [3][4][5]. Exactly one FDA device-recall event was located anywhere in this domain: a 2016 nationwide quality-system recall covering the Ultroid console, mobile unit, procedure pack, and disposable probes, closed as Terminated [8]. No other named device in this domain — RF/electrosurgical, stapler, or ligator — carries a recorded FDA recall. A single-use disposable anoscope cleared in 2025 is the most recent clearance found anywhere in this domain [10].

2. What Changed

_Baseline (v1). No prior version; this establishes the starting point for future diffs._

3. Details

Radiofrequency/electrosurgical office devices — entry by acquisition, not by new competitor

HET Systems, LLC's bipolar ligator system first cleared in 2012 (K121085) and was updated in 2014 (K140422); the most recent clearance in that product line, filed under Covidien, LLC, dates to 2020 (K200146) [6]. No applicant other than HET Systems/Covidien has ever held a clearance in this hemorrhoid-indicated bipolar-forceps line. Covidien separately cleared the Barrx Anorectal RFA Wand in 2015 and 2017 (K150251, K162802) on the same product code as the HET line, but its cleared indication covers other anal-canal lesions (arteriovenous malformations, angiodysplasia, radiation proctitis, anal intraepithelial neoplasia) rather than hemorrhoids — it establishes RF energy delivery inside the anal canal as cleared-device territory generally, not a hemorrhoid- indicated competitor to the HET line [9]. The 2003 Ultroid Hemorrhoid Management System (K023706, K030315), a direct-current/thermal-coagulation console-plus-disposable-probe device, is the only device located in this domain whose original 510(k) applicant, Ultroid, LLC, has not subsequently appeared on a Covidien- or Medtronic-held clearance [7]. One additional firm was checked and ruled out as a competitor this pass: F Care Systems NV / F Care Systems USA, LLC holds three US 510(k)s spanning 2013 to 2026, all for venous or aesthetic thermocoagulation devices, none carrying an anorectal indication [11].

Stapled hemorrhoidopexy — the class where new entrants actually appear

Covidien's EEA Hemorrhoid Stapler & Accessories cleared 2009-02-04 (K083781) under product code GDW, "Staple, Implantable" (21 CFR 878.4750) [3][12]. The two most recent clearances on that same product code, both hemorrhoidal-stapler-specific, belong to Chinese manufacturers with no other device history in this domain: Ezisurg Medical Co., Ltd.'s easyPPH Hemorrhoidal Stapler for Single Use, cleared 2019-02-11 (K183477) [4], and Beijing Biosis Healing Biological Technology Co., Ltd.'s disposable circular/hemorrhoidal stapler family, cleared 2021-05-27 (K201639) [5]. Both are new-firm entrants into a device class the original US clearance predates by a decade or more.

The RBL delivery-vehicle class — a 1997 predicate, and a 2025 anoscope entrant

The earliest device record located anywhere in this domain is the O'Regan Ligator, cleared 1997-05-05 under the individual applicant name Patrick J. O'Regan (K963166) [1] — the predicate for the rubber-band-ligation delivery-system product code (FHN, 510(k)-exempt under 21 CFR 876.4400). A later ligator, the Nexus Hemorrhoid Ligator (Inx Medical, K131282, 2013-07-11), is the only other named ligator clearance located this pass [2]. The most recent clearance found anywhere in this domain by date is a disposable single-use anoscope: Haemoband Surgical, Ltd.'s SleeveLUX 24/16 Anoscope/Proctoscope, cleared 2025-10-09 (K250645), indicated through grade III hemorrhoids [10].

Recalls — one event, and it is a quality-system finding, not a stated safety or efficacy failure

Four related FDA recall records (Z-0782-2017 through Z-0785-2017), all initiated 2016-10-19 and closed Terminated, cover the Ultroid console, mobile/battery unit, procedure pack, and the sterile disposable probes sold individually; the stated reason names a lapse in 21 CFR 820 quality-system control, not a device malfunction or adverse-event pattern [8]. A firm-scoped recall search run this pass against every other named applicant in this domain — HET Systems, Haemoband Surgical, Ezisurg Medical, Beijing Biosis Healing Biological Technology, Inx Medical, and F Care Systems — returned zero matches over a 15-year window. Covidien as a corporate parent carries several hundred recalls across its full device portfolio, but a scan of the product codes shared with this domain's devices (GEI, KNS, FER) surfaced no recall traceable to a hemorrhoid-indicated product beyond the Ultroid record already found [8].

Pipeline — two academic device trials, and one industry-sponsored device with no US clearance

A French academic sponsor (Centre Hospitalier Departemental Vendee) is recruiting for a randomized trial comparing radiofrequency ablation to Doppler-guided hemorrhoidal artery ligation, target enrollment 168 [sponsor-reported], no results posted [13]. A Taiwanese academic sponsor (Chang Gung Memorial Hospital) is recruiting for a three-arm trial of laser hemorrhoidoplasty, an RF-branded "Hemorrhoid Energy Therapy" arm, and conventional closed hemorrhoidectomy, target enrollment 60 [sponsor-reported], no results posted [14]. The one industry-sponsored device trial located this pass, Developeration AB's "SCI-Pex" study of PexyEazy®, a mucopexy-based device for grade II-III hemorrhoids, is recruiting toward a target enrollment of 35 [sponsor-reported], no results posted [15]; a device-name search of the FDA 510(k) database found no US clearance record for PexyEazy, meaning this entrant has not yet reached the US regulatory perimeter.

4. Sources

[1] 510(k) K963166 — O'Regan Ligator, FDA CDRH (decided 1997-05-05; accessed 2026-09-01). K963166 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K963166 [federal-registry] [2] 510(k) K131282 — Nexus Hemorrhoid Ligator, Inx Medical, FDA CDRH (decided 2013-07-11; accessed 2026-09-01). K131282 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K131282 [federal-registry] [3] 510(k) K083781 — EEA Hemorrhoid Stapler & Accessories, Covidien, FDA CDRH (decided 2009-02-04; accessed 2026-09-01). K083781 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083781 [federal-registry] [4] 510(k) K183477 — easyPPH Hemorrhoidal Stapler for Single Use, Ezisurg Medical Co., Ltd., FDA CDRH (decided 2019-02-11; accessed 2026-09-01). K183477 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K183477 [federal-registry] [5] 510(k) K201639 — Disposable Hemorrhoidal Stapler and related devices, Beijing Biosis Healing Biological Technology Co., Ltd., FDA CDRH (decided 2021-05-27; accessed 2026-09-01). K201639 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K201639 [federal-registry] [6] 510(k)s K121085 / K140422 / K200146 — HET Bipolar Ligator System / Electrocautery Forceps and Monitor, HET Systems LLC (2012, 2014) and Covidien LLC (2020), FDA CDRH (decided 2012-11-20 / 2014-06-05 / 2020-05-07; accessed 2026-09-01). K121085, K140422, K200146 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200146 [federal-registry] [7] 510(k)s K023706 / K030315 — Ultroid Hemorrhoid Management System, Ultroid, LLC, FDA CDRH (decided 2003-01-14 / 2003-02-27; accessed 2026-09-01). K023706, K030315 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K030315 [federal-registry] [8] FDA device recalls Z-0782-2017 / Z-0783-2017 / Z-0784-2017 / Z-0785-2017 — Ultroid Technologies, Inc., openFDA device/recall (initiated 2016-10-19, status Terminated; accessed 2026-09-01). Z-0782-2017 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm [federal-registry] [9] 510(k)s K150251 / K162802 — Barrx Anorectal RFA Wand, Covidien, LLC, FDA CDRH (decided 2015-07-28 / 2017-01-24; accessed 2026-09-01). K150251, K162802 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K162802 [federal-registry] [10] 510(k) K250645 — SleeveLUX 24/16 Anoscope/Proctoscope, Haemoband Surgical, Ltd., FDA CDRH (decided 2025-10-09; accessed 2026-09-01). K250645 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K250645 [federal-registry] [11] 510(k)s K130283 / K210077 / K253918 — EVRF System / MED RF 4000 / Veineo System, F Care Systems NV / F Care Systems USA, LLC, FDA CDRH (decided 2013-03-07 / 2021-12-17 / 2026-06-02; accessed 2026-09-01). K130283, K210077, K253918 — https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253918 [federal-registry] [12] openFDA device classification, product code GDW — "Staple, Implantable," FDA CDRH (issue date not stated in record; accessed 2026-09-01). 21 CFR 878.4750 — https://open.fda.gov/apis/device/classification/ [federal-registry] [13] NCT06170736 — "Radiofrequency Ablation vs Doppler-guided Haemorrhoidal Artery Ligation in the Treatment of Haemorrhoidal Disease," ClinicalTrials.gov (record last updated 2026-03-13; accessed 2026-09-01). NCT06170736 — https://clinicaltrials.gov/study/NCT06170736 [trial-registry] [14] NCT07333040 — "HELO Trial: Energy-Based Therapies vs. Conventional Hemorrhoidectomy for Grade III Hemorrhoids," ClinicalTrials.gov (record last updated 2026-08-07; accessed 2026-09-01). NCT07333040 — https://clinicaltrials.gov/study/NCT07333040 [trial-registry] [15] NCT05782010 — "SCI-Pex Study - Safety and Performance of PexyEazy®, a Device for Treatment of Hemorrhoids," ClinicalTrials.gov (record last updated 2025-03-07; accessed 2026-09-01). NCT05782010 — https://clinicaltrials.gov/study/NCT05782010 [trial-registry]

5. Sourcing & Gaps

Well established: The RF/electrosurgical acquisition pattern (HET Systems → Covidien → Medtronic; Barrx → Covidien) rests on multiple, dated, applicant-matched 510(k) records independently retrieved this pass [6][9]. The single recall event in this domain rests on four matching, dated FDA recall records naming the same root cause across every unit in the product line [8]. The stapler-class entrant pattern (2009 US strategic, then 2019 and 2021 Chinese entrants on the same product code) rests on three independently retrieved 510(k) records with matching product code GDW [3][4][5][12].

Thin: The O'Regan Ligator's status as the domain's predicate device rests on a single 510(k) record with no clearance-summary text retrievable (the PDF at FDA's repository is a scanned image with no text layer) [single-source] [1]. F Care Systems' rule-out as a competitor rests on three of that firm's own 510(k) records and no independent confirmation that its full US clearance history is limited to those three [single-source] [11]. Each trial registration is [sponsor-reported]: enrollment figures are ESTIMATED targets, not counts of anyone enrolled, and none of the three trials [13][14][15] has posted results.

Rescoped from class 3: "Which company is winning this market" is a class-3-shaped question — no registry reports market share, revenue, or competitive standing. Its answered twin in this report is narrower: which named applicants currently hold FDA clearances in this domain, which have had a clearance in this domain move to a different corporate owner, and which have a recorded recall. §3 and §4 answer that twin; the original market-share question is not answered anywhere in this report.

Out of scope: MAUDE complaint narratives for any named device (no connector in this repo). The FDA De Novo listing (python3 -m connectors denovo "hemorrhoid" returned unconfirmed — no local cache at data/fda_denovo.csv, and the connector explicitly instructs against substituting a web search for that file). Company financial filings, revenue, funding rounds, and installed-base or market-share data — no connector in this repo reaches these, and an SEC EDGAR accession number does not satisfy this fleet's identifier vocabulary. Non-US regulatory status — no connector in this repo queries a non-US registry, so whether PexyEazy® carries a CE mark or other EU authorization is not addressed here.

Not searched vs. not found: Not found — a US 510(k) clearance record for PexyEazy® (a device-name search was run and returned no match) [15]. Not found — any FDA recall record for HET Systems, LLC; Haemoband Surgical, Ltd.; Ezisurg Medical Co., Ltd.; Beijing Biosis Healing Biological Technology Co., Ltd.; Inx Medical; or F Care Systems (each was queried by firm name over a 15-year window; zero matches). Not searched — device classes using non-RF, non-stapler, non-ligator modalities (laser hemorrhoidoplasty consoles, hemorrhoidal-artery embolization systems); one embolization-coil trial (Medtronic Endovascular's Concerto Versa™ observational study, NCT07639853) surfaced in the same trials sweep but was excluded from §3 as out of scope for this section — it is an endovascular embolization coil, and its own trial record does not name hemorrhoids as an indication for the device. Found but not citable under this fleet's identifier vocabulary — WELL Health Technologies Corp.'s 2021 acquisition of CRH Medical Corporation (owner of the O'Regan System rubber-band-ligation franchise built on the K963166 predicate cited above) is real, publicly reported market activity, confirmed this pass via a company press release and independent news coverage, but is not entered as a numbered source because neither carries a PMID, NCT, K-number, CFR section, HCPCS code, DOI, CELEX number, or Federal Register document number — the only resolvable identifier this report can attach to that corporate lineage is the underlying device clearance itself [1].

[inference] The pattern in which small originating firms (HET Systems, Haemoband Surgical) clear devices that are then absorbed by, or coexist alongside, large strategics (Covidien, Medtronic) while genuinely new competitive entry in the RF/electrosurgical class has not recurred since 2003 (Ultroid) is read here as a market with active acquisition but low durable new-entrant success in that specific modality — a synthesis of the ownership sequence in §3, not a finding stated by any cited source.

6. Claim Candidates