K972979 is an FDA 510(k) clearance for the SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM. This device is classified as a Cystourethroscope (Class II - Special Controls, product code FBO).
Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on December 11, 1997, 122 days after receiving the submission on August 11, 1997.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K972979 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1997 |
| Decision Date | December 11, 1997 |
| Days to Decision | 122 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FBO — Cystourethroscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |