FDA 510(k)

LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER

K-Number: K123444 · 2013-01-30

ApplicantCovidien, Formerly Valleylab, A Division of Tyco H

Decision Date2013-01-30

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER is the device name listed in this FDA 510(k) record. The listed applicant is Covidien, Formerly Valleylab, A Division of Tyco H. It received FDA 510(k) clearance on 2013-01-30 under 510(k) number K123444. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER?

LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER is a medical device that received FDA 510(k) clearance on 2013-01-30. The listed applicant is Covidien, Formerly Valleylab, A Division of Tyco H. The 510(k) number is K123444.

When did LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER receive FDA 510(k) clearance?

LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER received FDA 510(k) clearance on 2013-01-30, under 510(k) number K123444.

Who is the listed applicant for LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER?

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

What is the FDA product code for LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER?

The FDA product code for LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER is GEI.

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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.