Panels › Gastroenterology, Urology › Product code FEB · Class 2
Accessories, Cleaning, For Endoscope
Regulation 876.1500
1510(k)s in 12 months (58 all time)
20recalls in 12 months (43 all time)
43recalls that name a 510(k)
Top companies in FEB
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Corporation of the Americas | 0 | 21 |
| STERIS Corporation | 4 | 9 |
| Advanced Sterilization Products | 4 | 8 |
| Custom Ultrasonics | 4 | 1 |
| Olympus Medical Systems Corp. | 5 | 0 |
| Keymed, Inc. | 4 | 0 |
| Medivators, Inc. | 4 | 0 |
| Aizu Olympus Co., Ltd. | 0 | 3 |
| Cox Medical Ent., Inc. | 3 | 0 |
| Medivators Reprocessing Systems | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 23, 1992 | K923672 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH Cox Medical Ent., Inc. | FEB |
| Oct 25, 1991 | K914442 | COX DISPOSABLE ENDOSCOPE CLEANING BRUSH Cox Medical Ent., Inc. | FEB |
| Jun 11, 1990 | K901439 | DISP. ENDOSCOPE CLEANING BRUSH - SQUEEKY CLEAN Telemed Systems, Inc. | FEB |
| Apr 15, 1985 | K850268 | SPARCO SCOPE GUARD Sparco, Inc. | FEB |
| Jul 19, 1984 | K840208 | CODE 17-ENDOSCOPE DEODORANT Knox Laboratories | FEB |
| Jan 14, 1983 | K830026 | FIBERSCOPE DISINFECTANT IRRIGATOR Keymed, Inc. | FEB |
| Jan 29, 1982 | K820152 | KEY MED LEEDS ENDOSCOPE DISINFECTOR Keymed, Inc. | FEB |
| Apr 8, 1981 | K810818 | KEY-MED FIBRESCOPE DISINFECTION TROLLEY Keymed, Inc. | FEB |
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