Auto Suture Locking Trocar

Laparoscope, General & Plastic Surgery

COVIDIEN

The following data is part of a premarket notification filed by Covidien with the FDA for Auto Suture Locking Trocar.

Pre-market Notification Details

Device IDK152565
510k NumberK152565
Device Name:Auto Suture Locking Trocar
ClassificationLaparoscope, General & Plastic Surgery
Applicant COVIDIEN 60 MIDDLETOWN AVENUE North Haven,  CT  06473
ContactMichael Koczocik
CorrespondentMichael Koczocik
COVIDIEN 60 MIDDLETOWN AVENUE North Haven,  CT  06473
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-09-09
Decision Date2015-10-09
Summary:summary

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