FDA Product Code
FDA Product Code FHN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4400
510(k) Clearances — 22 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | 2022-06-06 | Traditional | PDF ↗ |
| K172985 | Ligation Device | Leo Medical Co., Ltd. | 2018-06-14 | Traditional | PDF ↗ |
| K150718 | Wi-3 HAL-RAR System | Agency For Medical Innovations GmbH | 2015-06-12 | Traditional | PDF ↗ |
| K131282 | NEXUS HEMORRHOID LIGATOR | Inx Medical | 2013-07-11 | Traditional | PDF ↗ |
| K093497 | THD BANDY | Thd Spa | 2010-07-15 | Traditional | PDF ↗ |
| K091519 | HAEMOBAND MULTI-LIGATOR | Haemoband Surgical, Ltd. | 2009-07-28 | Traditional | PDF ↗ |
| K070881 | LEM HEMORRHOIDAL LIGATOR, MODELS A.5650, A.5660 | Sapimed S.P.A. | 2007-09-26 | Traditional | PDF ↗ |
| K020824 | SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 | Boston Scientific Corp | 2002-04-12 | Special | PDF ↗ |
| K020526 | MODIFICATION TO WILSON-COOK MULTIPLE BAND LIGATOR | Don Wilson/Wilson-Cook Medical, Inc. | 2002-03-19 | Special | PDF ↗ |
| K001236 | RIZA BAND STRETCHER (RBS)-60000 | R-Med, Inc. | 2000-07-17 | Traditional | PDF ↗ |
| K000297 | ERCHINGER HEMORRHOIDAL LIGATORS: SUCTION LIGATORS, MOD. ERCHINGER, RUDD, MCGIVNEY MOD. ERCHINGER | Erchinger Medizintecnik | 2000-04-24 | Traditional | PDF ↗ |
| K000397 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228; INJECTION SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODEL | Boston Scientific Corp | 2000-03-07 | Special | PDF ↗ |
| K981669 | SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR | Boston Scientific Corp | 1998-06-04 | Special | PDF ↗ |
| K974018 | WILSON-COOK 10 SHOT MULTI-BAND LIGATOR | Wilson-Cook Medical, Inc. | 1998-01-20 | Traditional | PDF ↗ |
| K963166 | O'REGAN LIGATOR | Patrick J. O'Regan | 1997-05-05 | Traditional | PDF ↗ |
| K964079 | SPEEDBAND MULTIPLE BAND LIGATOR | Boston Scientific Corp | 1997-02-13 | Traditional | PDF ↗ |
| K960020 | SOLO BAND LIGATOR | Surcraft, LLC | 1996-04-01 | Traditional | PDF ↗ |
| K952262 | SPEEDBAND | Boston Scientific Corp | 1996-02-29 | Traditional | PDF ↗ |
| K882297 | 1/2 CM REAR TIP EXTENDER (RTE) | American Medical Systems, Inc. | 1988-06-17 | Traditional | PDF ↗ |
| K880648 | ENDOSCOPIC ELASTIC BAND LIGATOR | Superior Healthcare Group, Inc. | 1988-04-06 | Traditional | PDF ↗ |
| K832192 | SUCTION-HEMORRHOID-LIGATOR | Research Endoscope Systems Intl. | 1983-12-27 | Traditional | PDF ↗ |
| K801352 | HEMORRHOIDAL LIGATION INSTR. SYSTEM | Depuy, Inc. | 1980-07-08 | Traditional | PDF ↗ |
Product code FHN · Class II · Gastroenterology, Urology. Data: openFDA.