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FDA 510(k)

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated

K-Number: K162047 · 2016-09-15

ApplicantCovidien
Decision Date2016-09-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated is the device name listed in this FDA 510(k) record. The listed applicant is Covidien. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K162047. 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, Nano-coated?

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Covidien. The 510(k) number is K162047.

When did LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated receive FDA 510(k) clearance?

LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated received FDA 510(k) clearance on 2016-09-15, under 510(k) number K162047.

Who is the listed applicant for LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated?

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 Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated?

The FDA product code for LigaSure Impact Curved, Large Jaw, Open Sealer/Divider, Nano-coated is GEI.

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Related Devices (Code: GEI)

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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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