The following data is part of a premarket notification filed by Ethicon, Inc. with the FDA for Versapoint Ii Bipolar Electrosurgery Generator, Versapoint Ii 44mm Angled Loop Electrode, Versapoint Ii Footswitch, Vers.
| Device ID | K111751 |
| 510k Number | K111751 |
| Device Name: | VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS |
| Classification | Coagulator-cutter, Endoscopic, Bipolar (and Accessories) |
| Applicant | ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Contact | Brian A Kanerviko |
| Correspondent | Brian A Kanerviko ETHICON, INC. ROUTE 22 WEST Somerville, NJ 08876 -0151 |
| Product Code | HIN |
| CFR Regulation Number | 884.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-22 |
| Decision Date | 2011-12-02 |
| Summary: | summary |