K994084 is an FDA 510(k) clearance for the SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES. This device is classified as a Image, Illumination, Fiberoptic, For Endoscope (Class II - Special Controls, product code FFS).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on January 20, 2000, 48 days after receiving the submission on December 3, 1999.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K994084 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 1999 |
| Decision Date | January 20, 2000 |
| Days to Decision | 48 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 |