K980636 is an FDA 510(k) clearance for the FIBER OPTIC ENDOILLUMINATION PROBE, a Image, Illumination, Fiberoptic, For Endoscope (Class II — Special Controls, product code FFS), submitted by Dutch Ophthalmic USA, Inc. (Kingston, US). The FDA issued a Cleared decision on May 20, 1998, 90 days after receiving the submission on February 19, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K980636 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 1998 |
| Decision Date | May 20, 1998 |
| Days to Decision | 90 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 |