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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 a medical device manufactured by Ethicon Endo-Surgery, LLC. It received FDA 510(k) clearance on 2016-09-09 under approval 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. It is manufactured by Ethicon Endo-Surgery, LLC. The 510(k) number is K160554.

When was Enseal X1 Large Jaw Tissue Sealer approved by the FDA?

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

What company makes Enseal X1 Large Jaw Tissue Sealer?

Enseal X1 Large Jaw Tissue Sealer is manufactured by Ethicon Endo-Surgery, LLC.

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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Related PubMed Literature

PMID: 39933996 Micro/Nanobiomimetic Iron-Based Scaffold Induces Vascularized Bone Regeneration To Repair Large Segmental Bone Defect in Load-Bearing Sites. ACS nano (2025)

Other Devices by Ethicon Endo-Surgery, LLC

K160128Endopath Electrosurgery Probe Plus II K160521ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm K151136HARMONIC HOOK K172580ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length K163523ECHELON CIRCULAR Powered Stapler K163548ENSEAL X1 Large Jaw Tissue Sealer

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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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