K926517 is an FDA 510(k) clearance for the ELMED LBC 50-P. This device is classified as a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II - Special Controls, product code HIN).
Submitted by Elmed, Inc. (Addison, US). The FDA issued a Cleared decision on November 15, 1994, 685 days after receiving the submission on December 30, 1992.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4150.
| 510(k) Number | K926517 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1992 |
| Decision Date | November 15, 1994 |
| Days to Decision | 685 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | HIN — Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4150 |