K082813 is an FDA 510(k) clearance for the STRYKER LED LIGHTSOURCE. This device is classified as a Light Source, Fiberoptic, Routine (Class II - Special Controls, product code FCW).
Submitted by Stryker Corp. (San Jose, US). The FDA issued a Cleared decision on December 19, 2008, 86 days after receiving the submission on September 24, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K082813 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2008 |
| Decision Date | December 19, 2008 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FCW — Light Source, Fiberoptic, Routine |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |