VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR


Device Classification Name

laparoscope, general & plastic surgery

510(k) Number K112349
Device Name VERSAPORT V2 BLADELESS OPTIICAL TROCAR AND/OR VERSAPORT BLADELESS OPTICAL TROCAR
Applicant
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H
60 middletown ave
north haven, 
CT 
06473

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

Correspodent Contact angela v arsdale
Regulation Number 876.1500
Classification Product Code
GCJ  
Date Received 08/16/2011
Decision Date 09/01/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

General & Plastic Surgery

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls