K761242 is an FDA 510(k) clearance for the TEFLON COATED RESECTOSCOPE SHEATH. This device is classified as a Resectoscope (Class II - Special Controls, product code FJL).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on December 16, 1976, 3 days after receiving the submission on December 13, 1976.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K761242 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1976 |
| Decision Date | December 16, 1976 |
| Days to Decision | 3 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FJL — Resectoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |