V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)…


Device Classification Name

suture, absorbable, synthetic, polyglycolic acid

510(k) Number K111442
Device Name V-LOC 180 ABSORBABLE RELOAD, V-LOC PBT NON-ABSORBABLE RELOAD, ENDO STITCH (TM) ENDOSCOPIC SUTURING DEVICE, SILS (TM)…
Applicant
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 middletown ave
north haven, 
CT 
06473

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

Correspodent Contact robert zott
Regulation Number 878.4493
Classification Product Code
GAM  
Subsequent Product Codes
GAT   OCW  
Date Received 05/24/2011
Decision Date 06/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No