VersaOne Reusable Positioning Trocar System

Laparoscope, General & Plastic Surgery

Covidien

The following data is part of a premarket notification filed by Covidien with the FDA for Versaone Reusable Positioning Trocar System.

Pre-market Notification Details

Device IDK201805
510k NumberK201805
Device Name:VersaOne Reusable Positioning Trocar System
ClassificationLaparoscope, General & Plastic Surgery
Applicant Covidien 60 Middletown Avenue North Haven,  CT  06473
ContactStephanie Wilde
CorrespondentStephanie Wilde
Covidien 60 Middletown Avenue North Haven,  CT  06473
Product CodeGCJ  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-07-01
Decision Date2020-08-26

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