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


Device Classification Name

coagulator-cutter, endoscopic, bipolar (and accessories)

510(k) Number K111751
Device Name VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS
Applicant
ETHICON, INC.
route 22 west
somerville, 
NJ 
08876 -0151

Applicant Contact brian a kanerviko
Correspondent
ETHICON, INC.
route 22 west
somerville, 
NJ 
08876 -0151

Correspodent Contact brian a kanerviko
Regulation Number 884.4150
Classification Product Code
HIN  
Subsequent Product Code
HIH  
Date Received 06/22/2011
Decision Date 12/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No