VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS

Coagulator-cutter, Endoscopic, Bipolar (and Accessories)

ETHICON, INC.

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.

Pre-market Notification Details

Device IDK111751
510k NumberK111751
Device Name:VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
ClassificationCoagulator-cutter, Endoscopic, Bipolar (and Accessories)
Applicant ETHICON, INC. ROUTE 22 WEST Somerville,  NJ  08876 -0151
ContactBrian A Kanerviko
CorrespondentBrian A Kanerviko
ETHICON, INC. ROUTE 22 WEST Somerville,  NJ  08876 -0151
Product CodeHIN  
CFR Regulation Number884.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-22
Decision Date2011-12-02
Summary:summary

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