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FDA 510(k)

VersaOne Reusable Positioning Trocar System

K-Number: K201805 · 2020-08-26

ApplicantCovidien
Decision Date2020-08-26
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VersaOne Reusable Positioning Trocar System is a medical device manufactured by Covidien. It received FDA 510(k) clearance on 2020-08-26 under approval number K201805. 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 Reusable Positioning Trocar System?

VersaOne Reusable Positioning Trocar System is a medical device that received FDA 510(k) clearance on 2020-08-26. It is manufactured by Covidien. The 510(k) number is K201805.

When was VersaOne Reusable Positioning Trocar System approved by the FDA?

VersaOne Reusable Positioning Trocar System received FDA 510(k) clearance on 2020-08-26, under approval number K201805.

What company makes VersaOne Reusable Positioning Trocar System?

VersaOne Reusable Positioning Trocar System is manufactured by Covidien.

What is the FDA product code for VersaOne Reusable Positioning Trocar System?

The FDA product code for VersaOne Reusable Positioning Trocar System is GCJ.

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Related Devices (Code: 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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