ENSEAL G2 TISSUS SEALERS


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K112033
Device Name ENSEAL G2 TISSUS SEALERS
Applicant
ETHICON ENDO-SUGERY, LLC
4545 creek rd.
cincinnati, 
OH 
45242

Applicant Contact donovan may
Correspondent
ETHICON ENDO-SUGERY, LLC
4545 creek rd.
cincinnati, 
OH 
45242

Correspodent Contact donovan may
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
HGI  
Date Received 07/15/2011
Decision Date 11/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls