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FDA 510(k)

WOUND PROTECTOR

K-Number: K120061 · 2012-03-27

ApplicantCovidien, Formerly US Surgical A Divison of Tyco H
Decision Date2012-03-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WOUND PROTECTOR 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 2012-03-27 under 510(k) number K120061. 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 WOUND PROTECTOR?

WOUND PROTECTOR is a medical device that received FDA 510(k) clearance on 2012-03-27. The listed applicant is Covidien, Formerly US Surgical A Divison of Tyco H. The 510(k) number is K120061.

When did WOUND PROTECTOR receive FDA 510(k) clearance?

WOUND PROTECTOR received FDA 510(k) clearance on 2012-03-27, under 510(k) number K120061.

Who is the listed applicant for WOUND PROTECTOR?

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 WOUND PROTECTOR?

The FDA product code for WOUND PROTECTOR 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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