FDA 510(k)

Enseal X1 Large Jaw Tissue Sealer

Numéro K : K160554 · 2016-09-09

Date de décision2016-09-09

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Enseal X1 Large Jaw Tissue Sealer is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K160554. 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 Enseal X1 Large Jaw Tissue Sealer?

Enseal X1 Large Jaw Tissue Sealer is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K160554.

When did Enseal X1 Large Jaw Tissue Sealer receive FDA 510(k) clearance?

Enseal X1 Large Jaw Tissue Sealer received FDA 510(k) clearance on 2016-09-09, under 510(k) number K160554.

Who is the listed applicant for Enseal X1 Large Jaw Tissue Sealer?

The FDA 510(k) record lists Ethicon Endo-Surgery, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enseal X1 Large Jaw Tissue Sealer?

The FDA product code for Enseal X1 Large Jaw Tissue Sealer is GEI.

Essais cliniques associés

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Source officielle

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