FDA 510(k)

LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER

K-Number: K130744 · 2013-04-05

Decision Date2013-04-05

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2013-04-05 under 510(k) number K130744. 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 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER?

LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER is a medical device that received FDA 510(k) clearance on 2013-04-05. The listed applicant is Covidien. The 510(k) number is K130744.

When did LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER receive FDA 510(k) clearance?

LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER received FDA 510(k) clearance on 2013-04-05, under 510(k) number K130744.

Who is the listed applicant for LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER?

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 LIGASURE 5MM BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER?

The FDA product code for LIGASURE 5MM BLUNT TIP LAPAROSCOPIC 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.