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FDA 510(k)

VersaOne Bladeless Trocar

K-Number: K162584 · 2016-10-18

ApplicantCovidien
Decision Date2016-10-18
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VersaOne Bladeless Trocar is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-10-18 under 510(k) number K162584. 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 Bladeless Trocar?

VersaOne Bladeless Trocar is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Covidien. The 510(k) number is K162584.

When did VersaOne Bladeless Trocar receive FDA 510(k) clearance?

VersaOne Bladeless Trocar received FDA 510(k) clearance on 2016-10-18, under 510(k) number K162584.

Who is the listed applicant for VersaOne Bladeless Trocar?

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 Bladeless Trocar?

The FDA product code for VersaOne Bladeless Trocar 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

View on FDA Database →

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