VersaOne Bladeless Trocar
K-Number: K162584 · 2016-10-18
ApplicantCovidien
Decision Date2016-10-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
VersaOne Bladeless Trocar is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-10-18 under approval number K162584. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VersaOne Bladeless Trocar?
VersaOne Bladeless Trocar is a medical device that received FDA 510(k) clearance on 2016-10-18. It is manufactured by Covidien. The 510(k) number is K162584.
When was VersaOne Bladeless Trocar approved by the FDA?
VersaOne Bladeless Trocar received FDA 510(k) clearance on 2016-10-18, under approval number K162584.
What company makes VersaOne Bladeless Trocar?
VersaOne Bladeless Trocar is manufactured by Covidien.
What is the FDA product code for VersaOne Bladeless Trocar?
The FDA product code for VersaOne Bladeless Trocar is GCJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.