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FDA 510(k)

VERSAPORT V2 BLADELESS OPTICAL TROCAR

K-Number: K130435 · 2013-03-14

ApplicantCovidien, Formerly US Surgical A Divison of Tyco H
Decision Date2013-03-14
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VERSAPORT V2 BLADELESS OPTICAL TROCAR is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. It received FDA 510(k) clearance on 2013-03-14 under 510(k) number K130435. 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 VERSAPORT V2 BLADELESS OPTICAL TROCAR?

VERSAPORT V2 BLADELESS OPTICAL TROCAR is a medical device that received FDA 510(k) clearance on 2013-03-14. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. The 510(k) number is K130435.

When did VERSAPORT V2 BLADELESS OPTICAL TROCAR receive FDA 510(k) clearance?

VERSAPORT V2 BLADELESS OPTICAL TROCAR received FDA 510(k) clearance on 2013-03-14, under 510(k) number K130435.

Who is the listed applicant for VERSAPORT V2 BLADELESS OPTICAL TROCAR?

The FDA 510(k) record lists Covidien, Formerly US Surgical A Divison of Tyco H as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSAPORT V2 BLADELESS OPTICAL TROCAR?

The FDA product code for VERSAPORT V2 BLADELESS OPTICAL TROCAR is GCJ.

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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.

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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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