Panels › Gastroenterology, Urology › Product code FCS · Class 2
Light, Catheter, Fiberoptic, Glass, Ureteral
Regulation 876.4020
0510(k)s in 12 months (10 all time)
0recalls in 12 months (3 all time)
2recalls that name a 510(k)
Top companies in FCS
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Endoscopy | 2 | 2 |
| Gabriel Medical, Inc. | 2 | 0 |
| Apple Medical Corp. | 1 | 0 |
| Cook Inc. | 0 | 1 |
| Cook Urological, Inc. | 1 | 0 |
| Laser Peripherals, LLC | 1 | 0 |
| Laserguide | 1 | 0 |
| Rocket of London, Ltd. | 1 | 0 |
| Stryker Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2017 | Cook Inc. Bush DL Ureteral Illuminating Catheter Set
Bush SL Ureteral Illuminating Catheter Set Terminated |
FCS | K923436 |
| Sep 16, 2008 | Stryker Endoscopy Stryker Ureteral Universal Kit, Model number 220-180-517, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which i Terminated |
FCS | None listed |
| Sep 16, 2008 | Stryker Endoscopy Stryker Ureteral Kit, Model number 220-180-516, The ureteral kit is a ureteral transillumination device with reusable illumination source and a fiberoptic light ureteral catheter kit which is provided Terminated |
FCS | K982542 |
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