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FDA 510(k)

Enseal X1 Large Jaw Tissue Sealer

K-Number: K160554 · 2016-09-09

ApplicantEthicon Endo-Surgery, LLC
Decision Date2016-09-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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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