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FDA 510(k)

ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,

K-Number: K131435 · 2013-10-03

ApplicantEthicon Endo-Surgery, LLC
Decision Date2013-10-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, 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 2013-10-03 under 510(k) number K131435. 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 ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,?

ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, is a medical device that received FDA 510(k) clearance on 2013-10-03. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K131435.

When did ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, receive FDA 510(k) clearance?

ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, received FDA 510(k) clearance on 2013-10-03, under 510(k) number K131435.

Who is the listed applicant for ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,?

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 G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW,?

The FDA product code for ENSEAL G2 TISSUE SEALER, STRAIGHT JAW, ENSEAL G2 TISSUE SEALER, CURVED JAW, ENSEAL TRIO TISSUE SEALER, 3 MM CURVED JAW, is 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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