Panels › Gastroenterology, Urology › Product code FHN · Class 2
Ligator, Hemorrhoidal
Regulation 876.4400
0510(k)s in 12 months (22 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in FHN
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 5 | 3 |
| Wilson-Cook Medical, Inc. | 1 | 1 |
| Agency For Medical Innovations GmbH | 1 | 0 |
| American Medical Systems, Inc. | 1 | 0 |
| Beijing Zksk Technology Co., Ltd. | 1 | 0 |
| Cook Endoscopy | 0 | 1 |
| Depuy, Inc. | 1 | 0 |
| Don Wilson/Wilson-Cook Medical, Inc. | 1 | 0 |
| Erchinger Medizintecnik | 1 | 0 |
| Haemoband Surgical, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 6, 2022 | K213223 | Multi-Band Ligator Beijing Zksk Technology Co., Ltd., CN | FHN |
| Jun 14, 2018 | K172985 | Ligation Device Leo Medical Co., Ltd., CN | FHN |
| Jun 12, 2015 | K150718 | Wi-3 HAL-RAR System Agency For Medical Innovations GmbH, AT | FHN |
| Jul 11, 2013 | K131282 | NEXUS HEMORRHOID LIGATOR Inx Medical | FHN |
| Jul 15, 2010 | K093497 | THD BANDY Thd Spa, IT | FHN |
| Jul 28, 2009 | K091519 | HAEMOBAND MULTI-LIGATOR Haemoband Surgical, Ltd. | FHN |
| Sep 26, 2007 | K070881 | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 Sapimed S.P.A. | FHN |
| Apr 12, 2002 | K020824 | SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 Boston Scientific Corp | FHN |
| Mar 19, 2002 | K020526 | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR Don Wilson/Wilson-Cook Medical, Inc. | FHN |
| Jul 17, 2000 | K001236 | RIZA BAND STRETCHER (RBS)-60000 R-Med, Inc. | FHN |
| Apr 24, 2000 | K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER Erchinger Medizintecnik, NL | FHN |
| Mar 7, 2000 | K000397 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL Boston Scientific Corp | FHN |
| Jun 4, 1998 | K981669 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR Boston Scientific Corp | FHN |
| Jan 20, 1998 | K974018 | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR Wilson-Cook Medical, Inc. | FHN |
| May 5, 1997 | K963166 | O'REGAN LIGATOR Patrick J. O'Regan, CA | FHN |
| Feb 13, 1997 | K964079 | SPEEDBAND MULTIPLE BAND LIGATOR Boston Scientific Corp | FHN |
| Apr 1, 1996 | K960020 | SOLO BAND LIGATOR Surcraft, LLC | FHN |
| Feb 29, 1996 | K952262 | SPEEDBAND Boston Scientific Corp | FHN |
| Jun 17, 1988 | K882297 | 1/2 CM REAR TIP EXTENDER (RTE) American Medical Systems, Inc. | FHN |
| Apr 6, 1988 | K880648 | ENDOSCOPIC ELASTIC BAND LIGATOR Superior Healthcare Group, Inc. | FHN |
| Dec 27, 1983 | K832192 | SUCTION-HEMORRHOID-LIGATOR Research Endoscope Systems Intl. | FHN |
| Jul 8, 1980 | K801352 | HEMORRHOIDAL LIGATION INSTR. SYSTEM Depuy, Inc. | FHN |
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