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FDA 510(k)

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm

K-Number: K160230 · 2016-03-01

ApplicantCovidien
Decision Date2016-03-01
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-03-01 under approval number K160230. 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 Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm is a medical device that received FDA 510(k) clearance on 2016-03-01. It is manufactured by Covidien. The 510(k) number is K160230.

When was VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm approved by the FDA?

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm received FDA 510(k) clearance on 2016-03-01, under approval number K160230.

What company makes VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm is manufactured by Covidien.

What is the FDA product code for VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm?

The FDA product code for VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm 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.

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