K933962 is an FDA 510(k) clearance for the GM CONTINUOUS FLOW BIOPSY PROBE, a Resectoscope, Working Element (Class II — Special Controls, product code FDC), submitted by Gm Engineering, Inc. (La Verne, US). The FDA issued a Cleared decision on February 25, 1994, 196 days after receiving the submission on August 13, 1993. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K933962 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 13, 1993 |
| Decision Date | February 25, 1994 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FDC — Resectoscope, Working Element |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 876.1500 |