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FDA 510(k)

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula

K-Number: K213818 · 2022-06-27

ApplicantCovidien
Decision Date2022-06-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2022-06-27 under approval number K213818. 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 with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula?

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula is a medical device that received FDA 510(k) clearance on 2022-06-27. It is manufactured by Covidien. The 510(k) number is K213818.

When was VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula approved by the FDA?

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula received FDA 510(k) clearance on 2022-06-27, under approval number K213818.

What company makes VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula?

VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula is manufactured by Covidien.

What is the FDA product code for VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula?

The FDA product code for VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula 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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