FHN · Class II · 21 CFR 876.4400

FDA Product Code FHN: Ligator, Hemorrhoidal

Leading manufacturers include Boston Scientific Corp, Sapimed S.P.A. and Inx Medical.

22
Total
22
Cleared
116d
Avg days
1980
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Ligator, Hemorrhoidal Devices (Product Code FHN)

22 devices
1–22 of 22
Cleared Jun 06, 2022
Multi-Band Ligator
K213223
Beijing Zksk Technology Co., Ltd.
Gastroenterology & Urology · 250d
Cleared Jun 14, 2018
Ligation Device
K172985
Leo Medical Co., Ltd.
Gastroenterology & Urology · 260d
Cleared Jun 12, 2015
Wi-3 HAL-RAR System
K150718
Agency For Medical Innovations GmbH
Gastroenterology & Urology · 85d
Cleared Jul 11, 2013
NEXUS HEMORRHOID LIGATOR
K131282
Inx Medical
Gastroenterology & Urology · 66d
Cleared Sep 26, 2007
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660
K070881
Sapimed S.P.A.
Gastroenterology & Urology · 180d
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
K020824
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Mar 07, 2000
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228
K000397
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Jun 04, 1998
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR
K981669
Boston Scientific Corp
Gastroenterology & Urology · 23d
Cleared Jan 20, 1998
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR
K974018
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared May 05, 1997
O'REGAN LIGATOR
K963166
Patrick J. O'Regan
Gastroenterology & Urology · 264d
Cleared Feb 13, 1997
SPEEDBAND MULTIPLE BAND LIGATOR
K964079
Boston Scientific Corp
Gastroenterology & Urology · 125d
Cleared Apr 01, 1996
SOLO BAND LIGATOR
K960020
Surcraft, LLC
Gastroenterology & Urology · 90d
Cleared Feb 29, 1996
SPEEDBAND
K952262
Boston Scientific Corp
Gastroenterology & Urology · 290d
Cleared Jun 17, 1988
1/2 CM REAR TIP EXTENDER (RTE)
K882297
American Medical Systems, Inc.
Gastroenterology & Urology · 15d
Cleared Jul 08, 1980
HEMORRHOIDAL LIGATION INSTR. SYSTEM
K801352
Depuy, Inc.
Gastroenterology & Urology · 29d

About Product Code FHN - Regulatory Context

510(k) Submission Activity

22 total 510(k) submissions under product code FHN since 1980, with 22 receiving FDA clearance (average review time: 116 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.