K924200 is an FDA 510(k) clearance for the REFLEX(R) ESC, a Coagulator-cutter, Endoscopic, Unipolar (and Accessories) (Class II — Special Controls, product code KNF), submitted by Richard-Allan Medical Ind., Inc. (Richland, US). The FDA issued a Cleared decision on February 22, 1994, 551 days after receiving the submission on August 20, 1992. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4160.
| 510(k) Number | K924200 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 20, 1992 |
| Decision Date | February 22, 1994 |
| Days to Decision | 551 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | KNF — Coagulator-cutter, Endoscopic, Unipolar (and Accessories) |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4160 |