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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 the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2020-08-26 under 510(k) 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. The listed applicant is Covidien. The 510(k) number is K201805.

When did VersaOne Reusable Positioning Trocar System receive FDA 510(k) clearance?

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

Who is the listed applicant for VersaOne Reusable Positioning Trocar System?

The FDA 510(k) record lists Covidien as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Covidien as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 119 devices →

Related Devices (Code: GCJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.