Panels › Gastroenterology, Urology › Product code FAS · Class 2
Electrode, Electrosurgical, Active, Urological
Regulation 876.4300
1510(k)s in 12 months (58 all time)
0recalls in 12 months (9 all time)
8recalls that name a 510(k)
Top companies in FAS
| Company | 510(k)s | Recalls |
|---|---|---|
| Olympus Winter & Ibe GmbH | 6 | 0 |
| Arthrocare Corp. | 5 | 0 |
| Aomori Olympus Co., Ltd. | 0 | 4 |
| Omnitech Systems, Inc. | 4 | 0 |
| C.R. Bard, Inc. | 2 | 1 |
| Greenwald Surgical Co., Inc. | 3 | 0 |
| Gyrus Acmi, Inc. | 2 | 1 |
| Olympus Corporation of the Americas | 0 | 3 |
| American Medical Systems, Inc. | 2 | 0 |
| Applied Urology, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 1994 | K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS Olympus Corp. | FAS |
| Apr 1, 1994 | K933175 | GREENWALD CONTROL TIP URETEROSCOPIC ELECTRODE Greenwald Surgical Co., Inc. | FAS |
| Apr 1, 1994 | K933174 | GREENWALD FLEXIBLE ENDOSCOPIC ELECTRODE Greenwald Surgical Co., Inc. | FAS |
| Apr 1, 1994 | K933173 | GREENWALD CONTROL-TIP CYSTOSCOPIC ELECTRODE Greenwald Surgical Co., Inc. | FAS |
| Jul 23, 1992 | K915219 | URETHRAL ELECTRODE SHEATH Applied Urology, Inc. | FAS |
| Jan 31, 1991 | K905731 | FLEXIBLE ENDOSCOPIC ELECTRODE Applied Urology, Inc. | FAS |
| Dec 18, 1990 | K903162 | FLEXIBLE ENDOSCOPIC ELECTRODES North American Sterilization & Packaging Co. | FAS |
| Dec 18, 1990 | K903156 | CONTROL-TIP CYSTOSCOPIC ELECTRODES North American Sterilization & Packaging Co. | FAS |
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