K760174 is an FDA 510(k) clearance for the ADAPTER, RESECTOSCOPE. This device is classified as a Resectoscope, Working Element (Class II - Special Controls, product code FDC).
Submitted by V. Mueller O.V. Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1976, 55 days after receiving the submission on July 6, 1976.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K760174 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 06, 1976 |
| Decision Date | August 30, 1976 |
| Days to Decision | 55 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | FDC — Resectoscope, Working Element |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |