FDA 510(k)

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

Numéro K : K162047 · 2016-09-15

Date de décision2016-09-15

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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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Source officielle

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