K082925 is an FDA 510(k) clearance for the XENON-100 SCB LIGHT SOURCE, MODEL 20132620. This device is classified as a Light Source, Endoscope, Xenon Arc (Class II — Special Controls, product code GCT).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on December 18, 2008, 78 days after receiving the submission on October 1, 2008.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K082925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2008 |
| Decision Date | December 18, 2008 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GCT — Light Source, Endoscope, Xenon Arc |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |