K945102 is an FDA 510(k) clearance for the MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE, a Image, Illumination, Fiberoptic, For Endoscope (Class II — Special Controls, product code FFS), submitted by Alm Surgical Equipment, Inc. (Anaheim, US). The FDA issued a Cleared decision on November 4, 1994, 17 days after receiving the submission on October 18, 1994. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K945102 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 18, 1994 |
| Decision Date | November 04, 1994 |
| Days to Decision | 17 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 |