K061548 is an FDA 510(k) clearance for the STRYKER URETERAL ILLUMINATION SYSTEM IV. This device is classified as a Light, Catheter, Fiberoptic, Glass, Ureteral (Class II - Special Controls, product code FCS).
Submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on September 28, 2006, 115 days after receiving the submission on June 5, 2006.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4020.
| 510(k) Number | K061548 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2006 |
| Decision Date | September 28, 2006 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCS — Light, Catheter, Fiberoptic, Glass, Ureteral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4020 |