K893440 is an FDA 510(k) clearance for the FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150. This device is classified as a Image, Illumination, Fiberoptic, For Endoscope (Class II - Special Controls, product code FFS).
Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 28, 1989, 86 days after receiving the submission on May 3, 1989.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K893440 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 1989 |
| Decision Date | July 28, 1989 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FFS — Image, Illumination, Fiberoptic, For Endoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |