Atlas FDA

FHN

22 FDA 510(k) clearances · Product code

90 daysmedian time to decision
260 days90th percentile
22clearances measured

FDA profile

Official device name
Ligator, Hemorrhoidal
Device class
Class II (moderate risk)
Regulation
21 CFR 876.4400
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2018: 318 · 2019: 372 · 2020: 70 · 2021: 16 · 2022: 60 · 2023: 47
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Multi-Band Ligator (K213223)Beijing Zksk Technology Co., Ltd.2022-06-06
Ligation Device (K172985)Leo Medical Co., Ltd.2018-06-14
Wi-3 HAL-RAR System (K150718)Agency For Medical Innovations GmbH2015-06-12
NEXUS HEMORRHOID LIGATOR (K131282)Inx Medical2013-07-11
THD BANDY (K093497)Thd Spa2010-07-15
HAEMOBAND MULTI-LIGATOR (K091519)Haemoband Surgical, Ltd.2009-07-28
LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 (K070881)Sapimed S.P.A.2007-09-26
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 (K020824)Boston Scientific Corp2002-04-12
MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR (K020526)Don Wilson/Wilson-Cook Medical, Inc.2002-03-19
RIZA BAND STRETCHER (RBS)-60000 (K001236)R-Med, Inc.2000-07-17
ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER (K000297)Erchinger Medizintecnik2000-04-24
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL (K000397)Boston Scientific Corp2000-03-07
SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR (K981669)Boston Scientific Corp1998-06-04
WILSON-COOK 10 SHOT MULTI-BAND LIGATOR (K974018)Wilson-Cook Medical, Inc.1998-01-20
O'REGAN LIGATOR (K963166)Patrick J. O'Regan1997-05-05
SPEEDBAND MULTIPLE BAND LIGATOR (K964079)Boston Scientific Corp1997-02-13
SOLO BAND LIGATOR (K960020)Surcraft, LLC1996-04-01
SPEEDBAND (K952262)Boston Scientific Corp1996-02-29
1/2 CM REAR TIP EXTENDER (RTE) (K882297)American Medical Systems, Inc.1988-06-17
ENDOSCOPIC ELASTIC BAND LIGATOR (K880648)Superior Healthcare Group, Inc.1988-04-06
SUCTION-HEMORRHOID-LIGATOR (K832192)Research Endoscope Systems Intl.1983-12-27
HEMORRHOIDAL LIGATION INSTR. SYSTEM (K801352)Depuy, Inc.1980-07-08

Track FHN automatically

Every clearance here is in the API, with alerts when new ones post.