K932456 is an FDA 510(k) clearance for the JARIT SURGICAL INSTRUMENTS. This device is classified as a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II - Special Controls, product code KNF).
Submitted by J. Jamner Surgical Instruments, Inc. (Great Neck, US). The FDA issued a Cleared decision on April 21, 1994, 335 days after receiving the submission on May 21, 1993.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K932456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1993 |
| Decision Date | April 21, 1994 |
| Days to Decision | 335 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | KNF — Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4160 |