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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 20, 2015 | K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] Stryker Endoscopy | FCS |
| Sep 28, 2006 | K061548 | STRYKER URETERAL ILLUMINATION SYSTEM IV Stryker Corp. | FCS |
| Sep 22, 1998 | K982542 | STRYKER URETERAL ILLUMINATOR SYSTEM III Stryker Endoscopy | FCS |
| Aug 15, 1995 | K943801 | URIGLOW TRANSILLUMINATING URETERIC STENT MODEL Rocket of London, Ltd., GB | FCS |
| Feb 7, 1995 | K945088 | GABRIEL URETERAL ILLUMINATOR SYSTEM II Gabriel Medical, Inc. | FCS |
| Oct 5, 1994 | K941506 | URETERAL ILLUMINATOR Apple Medical Corp. | FCS |
| May 2, 1994 | K940019 | GABRIEL URETERAL ILLUMINATOR SYSTEM Gabriel Medical, Inc. | FCS |
| Mar 5, 1993 | K923436 | ILLUMINATED URETERAL CATHETER Cook Urological, Inc. | FCS |
| Mar 23, 1988 | K874680 | LASEGUIDE 600A, 600B, 400A, AND 400B Laser Peripherals, LLC | FCS |
| Mar 22, 1988 | K880071 | SURGI-LIGHT ND:YAG LASER FOR UROLOGICAL USE Laserguide | FCS |
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