K945686 is an FDA 510(k) clearance for the KARL STORZ KNIVES, CURETTES. This device is classified as a Urethrotome (Class II - Special Controls, product code EZO).
Submitted by KARL STORZ Endoscopy-America, Inc. (Culver City, US). The FDA issued a Cleared decision on February 13, 1995, 84 days after receiving the submission on November 21, 1994.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4770.
| 510(k) Number | K945686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1994 |
| Decision Date | February 13, 1995 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZO — Urethrotome |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.4770 |