510(k) K111751

VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS by ETHICON, Inc. — Product Code HIN

K111751 is an FDA 510(k) premarket notification submitted by ETHICON, Inc. for the device "VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS". The FDA issued a decision of Substantially Equivalent on December 2, 2011. The device falls under product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)), a Class II device regulated under 21 CFR 884.4150. ETHICON, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2011
Date Received
June 22, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Device Class
Class II
Regulation Number
884.4150
Review Panel
OB
Submission Type