K954050 is an FDA 510(k) clearance for the RESECTOSCOPES. This device is classified as a Resectoscope (Class II - Special Controls, product code FJL).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on November 22, 1995, 85 days after receiving the submission on August 29, 1995.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K954050 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 29, 1995 |
| Decision Date | November 22, 1995 |
| Days to Decision | 85 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | FJL — Resectoscope |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1500 |