K111751 is an FDA 510(k) clearance for the VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS. This device is classified as a Coagulator-cutter, Endoscopic, Bipolar (and Accessories) (Class II - Special Controls, product code HIN).
Submitted by Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on December 2, 2011, 163 days after receiving the submission on June 22, 2011.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4150.
| 510(k) Number | K111751 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 2011 |
| Decision Date | December 02, 2011 |
| Days to Decision | 163 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Summary PDF |
| Product Code | HIN — Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4150 |