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 |