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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2011 | Boston Scientific Corporation The Resolution II Clip, 155 cm size and 235 cm size, Boxes of 1, 10, and 20 clips consists of a pre-loaded, radiopaque single use clip on a flexible delivery system.
Endoscopic Clipping Device, Hemo Terminated |
FHN | K102764 |
| Oct 19, 2010 | Cook Endoscopy Ten Shooter Saeed Multi-Band Ligator, Rx Only, Wilson Cook Medical 4900 Bethania Station Road, Winston-Salem, NC 27105
This device is used to endoscopically ligate esophageal varices at or above the g Terminated |
FHN | K974018 |
| Sep 2, 2009 | Boston Scientific Corporation Boston Scientific Clipping Device, Resolution Clip, working length 235 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522610 (1 clip) and M00 Terminated |
FHN | K040148 |
| Sep 2, 2009 | Boston Scientific Corporation Boston Scientific Clipping Device, Resolution Clip, working length 155 cm, working channel 2.8 mm, Manufactured for Boston Scientific Corporation, Natick, MA; Product codes M00522600 (1 clip) and M00 Terminated |
FHN | K040148 |
| Jul 20, 2004 | Wilson-Cook Medical Inc Four Shooter Saeed Multi-Band Ligator Terminated |
FHN | K944220 |
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