K960757 is an FDA 510(k) clearance for the KARL STORZ URETER RESECTOSCOPE. 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 May 1, 1996, 68 days after receiving the submission on February 23, 1996.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K960757 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 23, 1996 |
| Decision Date | May 01, 1996 |
| Days to Decision | 68 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 |