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FDA 510(k)

VersaOne Bladed Trocar 5mm

K-Number: K152149 · 2016-01-22

ApplicantCovidien
Decision Date2016-01-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VersaOne Bladed Trocar 5mm is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2016-01-22 under approval number K152149. 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 Bladed Trocar 5mm?

VersaOne Bladed Trocar 5mm is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Covidien. The 510(k) number is K152149.

When was VersaOne Bladed Trocar 5mm approved by the FDA?

VersaOne Bladed Trocar 5mm received FDA 510(k) clearance on 2016-01-22, under approval number K152149.

What company makes VersaOne Bladed Trocar 5mm?

VersaOne Bladed Trocar 5mm is manufactured by Covidien.

What is the FDA product code for VersaOne Bladed Trocar 5mm?

The FDA product code for VersaOne Bladed Trocar 5mm is GCJ.

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Related Devices (Code: GCJ)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.