K962595 is an FDA 510(k) clearance for the KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS. This device is classified as a Image, Illumination, Fiberoptic, For Endoscope (Class II - Special Controls, product code FFS).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on September 4, 1996, 64 days after receiving the submission on July 2, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K962595 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1996 |
| Decision Date | September 04, 1996 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FFS — Image, Illumination, Fiberoptic, For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |