Product Code: FHN FDA class 2 21 CFR 876.4400

Ligator, Hemorrhoidal

Gastroenterology, Urology

The Hemorrhoidal Ligator is a device used to apply rubber bands or other ligatures around the base of internal hemorrhoids, causing them to shrink and fall off through ischemic necrosis. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket clearance. The product code is FHN, regulated under 21 CFR 876.4400, within the Gastroenterology, Urology medical specialty.

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FEI Numbers

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Basic Information

Product Code: FHN
Device Class: FDA class 2
Regulation Number: 876.4400
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 22 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K213223	Multi-Band Ligator	Jun 06, 2022	Substantially Equivalent	Beijing Zksk Technology Co., Ltd.
K172985	Ligation Device	Jun 14, 2018	Substantially Equivalent	Leo Medical Co., Ltd.
K150718	Wi-3 HAL-RAR System	Jun 12, 2015	Substantially Equivalent	Agency For Medical Innovations GmbH
K131282	NEXUS HEMORRHOID LIGATOR	Jul 11, 2013	Substantially Equivalent	Inx Medical
K093497	THD BANDY	Jul 15, 2010	Substantially Equivalent	Thd Spa
K091519	HAEMOBAND MULTI-LIGATOR	Jul 28, 2009	Substantially Equivalent	Haemoband Surgical, Ltd.
K070881	LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660	Sep 26, 2007	Substantially Equivalent	Sapimed S.P.A.
K020824	SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238	Apr 12, 2002	Substantially Equivalent	Boston Scientific Corp
K020526	MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR	Mar 19, 2002	Substantially Equivalent	Don Wilson/Wilson-Cook Medical, Inc.
K001236	RIZA BAND STRETCHER (RBS)-60000	Jul 17, 2000	Substantially Equivalent	R-Med, Inc.
K000297	ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER	Apr 24, 2000	Substantially Equivalent	Erchinger Medizintecnik
K000397	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL	Mar 07, 2000	Substantially Equivalent	Boston Scientific Corp
K981669	SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR	Jun 04, 1998	Substantially Equivalent	Boston Scientific Corp
K974018	WILSON-COOK 10 SHOT MULTI-BAND LIGATOR	Jan 20, 1998	Substantially Equivalent	Wilson-Cook Medical, Inc.
K963166	O'REGAN LIGATOR	May 05, 1997	Substantially Equivalent	Patrick J. O'Regan
K964079	SPEEDBAND MULTIPLE BAND LIGATOR	Feb 13, 1997	Substantially Equivalent	Boston Scientific Corp
K960020	SOLO BAND LIGATOR	Apr 01, 1996	Substantially Equivalent	Surcraft, LLC
K952262	SPEEDBAND	Feb 29, 1996	Substantially Equivalent	Boston Scientific Corp
K882297	1/2 CM REAR TIP EXTENDER (RTE)	Jun 17, 1988	Substantially Equivalent	American Medical Systems, Inc.
K880648	ENDOSCOPIC ELASTIC BAND LIGATOR	Apr 06, 1988	Substantially Equivalent	Superior Healthcare Group, Inc.
K832192	SUCTION-HEMORRHOID-LIGATOR	Dec 27, 1983	Substantially Equivalent	Research Endoscope Systems Intl.
K801352	HEMORRHOIDAL LIGATION INSTR. SYSTEM	Jul 08, 1980	Substantially Equivalent	Depuy, Inc.