K072521 is an FDA 510(k) clearance for the COOK FIBER OPTIC BUNDLE AND FLEXOR DEFLECTING ACCESS SHEATH, a Image, Illumination, Fiberoptic, For Endoscope (Class II — Special Controls, product code FFS), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on November 20, 2007, 74 days after receiving the submission on September 7, 2007. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K072521 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 07, 2007 |
| Decision Date | November 20, 2007 |
| Days to Decision | 74 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 |