ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS


Device Classification Name

staple, implantable

510(k) Number K111825
Device Name ENDO GIA(TM) STAPLERS, DST SERIES(TM) GIA(TM) STAPLERS, DST SERIES(TM) TA(TM) STAPLERS
Applicant
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 middletown ave
north haven, 
CT 
06473

Applicant Contact frank gianelli
Correspondent
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 middletown ave
north haven, 
CT 
06473

Correspodent Contact frank gianelli
Regulation Number 878.4750
Classification Product Code
GDW  
Date Received 06/28/2011
Decision Date 10/25/2011
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