ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM


Device Classification Name

electrosurgical, cutting & coagulation & accessories

510(k) Number K072177
Device Name ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM
Applicant
SURGRX, INC.
101 saginaw dr.
redwood city, 
CA 
94063

Applicant Contact linda oleson
Correspondent
SURGRX, INC.
101 saginaw dr.
redwood city, 
CA 
94063

Correspodent Contact linda oleson
Regulation Number 878.4400
Classification Product Code
GEI  
Subsequent Product Code
HGI  
Date Received 08/06/2007
Decision Date 09/05/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls