K942626 is an FDA 510(k) clearance for the CONTINUOUS FLOW BIOPSY PROBE. This device is classified as 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 May 30, 1995, 362 days after receiving the submission on June 2, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K942626 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 1994 |
| Decision Date | May 30, 1995 |
| Days to Decision | 362 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FDC — Resectoscope, Working Element |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |