Browse hierarchy: [Gastroenterology, Urology (GU)](/submissions/GU) → [Subpart E — Surgical Devices](/submissions/GU/subpart-e%E2%80%94surgical-devices) → [21 CFR 876.4400](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4400) → FHN — Ligator, Hemorrhoidal # FHN · Ligator, Hemorrhoidal _Gastroenterology, Urology · 21 CFR 876.4400 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN ## Overview - **Product Code:** FHN - **Device Name:** Ligator, Hemorrhoidal - **Regulation:** [21 CFR 876.4400](/submissions/GU/subpart-e%E2%80%94surgical-devices/876.4400) - **Device Class:** 2 - **Review Panel:** [Gastroenterology, Urology](/submissions/GU) ## Identification A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid. ## Classification Rationale Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. ## Special Controls *Classification.* Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9. ## Recent Cleared Devices (20 of 22) Showing 20 most recent of 22 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K213223](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K213223.md) | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | Jun 6, 2022 | SESE | | [K172985](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K172985.md) | Ligation Device | Leo Medical Co., Ltd. | Jun 14, 2018 | SESE | | [K150718](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K150718.md) | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | Jun 12, 2015 | SESE | | [K131282](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K131282.md) | NEXUS HEMORRHOID LIGATOR | Inx Medical | Jul 11, 2013 | SESE | | [K093497](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K093497.md) | THD BANDY | Thd Spa | Jul 15, 2010 | SESE | | [K091519](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K091519.md) | HAEMOBAND MULTI-LIGATOR | Haemoband Surgical, Ltd. | Jul 28, 2009 | SESE | | [K070881](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K070881.md) | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | Sapimed S.P.A. | Sep 26, 2007 | SESE | | [K020824](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K020824.md) | SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 | Boston Scientific Corp | Apr 12, 2002 | SESE | | [K020526](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K020526.md) | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR | Don Wilson/Wilson-Cook Medical, Inc. | Mar 19, 2002 | SESE | | [K001236](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K001236.md) | RIZA BAND STRETCHER (RBS)-60000 | R-Med, Inc. | Jul 17, 2000 | SESE | | [K000297](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K000297.md) | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER | Erchinger Medizintecnik | Apr 24, 2000 | SESE | | [K000397](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K000397.md) | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL | Boston Scientific Corp | Mar 7, 2000 | SESE | | [K981669](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K981669.md) | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR | Boston Scientific Corp | Jun 4, 1998 | SESE | | [K974018](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K974018.md) | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR | Wilson-Cook Medical, Inc. | Jan 20, 1998 | SESE | | [K963166](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K963166.md) | O'REGAN LIGATOR | Patrick J. O'Regan | May 5, 1997 | SESE | | [K964079](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K964079.md) | SPEEDBAND MULTIPLE BAND LIGATOR | Boston Scientific Corp | Feb 13, 1997 | SESE | | [K960020](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K960020.md) | SOLO BAND LIGATOR | Surcraft, LLC | Apr 1, 1996 | SESE | | [K952262](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K952262.md) | SPEEDBAND | Boston Scientific Corp | Feb 29, 1996 | SESE | | [K882297](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K882297.md) | 1/2 CM REAR TIP EXTENDER (RTE) | American Medical Systems, Inc. | Jun 17, 1988 | SESE | | [K880648](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN/K880648.md) | ENDOSCOPIC ELASTIC BAND LIGATOR | Superior Healthcare Group, Inc. | Apr 6, 1988 | SESE | ## Top Applicants - Boston Scientific Corp — 5 clearances - Agency For Medical Innovations GmbH — 1 clearance - American Medical Systems, Inc. — 1 clearance - Beijing Zksk Technology Co., Ltd. — 1 clearance - Depuy, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/FHN) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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