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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K081169
Device Name AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR
Applicant
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Applicant Contact TIM LOHNES
Correspondent
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES
60 MIDDLETOWN AVENUE
NORTH HAVEN,  CT  06473
Correspondent Contact TIM LOHNES
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received04/24/2008
Decision Date 05/23/2008
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
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