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FDA 510(k)

ENSEAL G2 TISSUS SEALERS

K-Number: K112033 · 2011-11-08

ApplicantEthicon Endo-Sugery, LLC
Decision Date2011-11-08
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENSEAL G2 TISSUS SEALERS is the device name listed in this FDA 510(k) record. The listed applicant is Ethicon Endo-Sugery, LLC. It received FDA 510(k) clearance on 2011-11-08 under 510(k) number K112033. 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 TISSUS SEALERS?

ENSEAL G2 TISSUS SEALERS is a medical device that received FDA 510(k) clearance on 2011-11-08. The listed applicant is Ethicon Endo-Sugery, LLC. The 510(k) number is K112033.

When did ENSEAL G2 TISSUS SEALERS receive FDA 510(k) clearance?

ENSEAL G2 TISSUS SEALERS received FDA 510(k) clearance on 2011-11-08, under 510(k) number K112033.

Who is the listed applicant for ENSEAL G2 TISSUS SEALERS?

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

What is the FDA product code for ENSEAL G2 TISSUS SEALERS?

The FDA product code for ENSEAL G2 TISSUS SEALERS is GEI.

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Other records listing Ethicon Endo-Sugery, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K101990ETHICON ENDO-SURGERY GENERATOR G11, MODEL GEN11K110699LIGAMAX 5K091211EES SINGLE SITE LAPAROSCOPIC SEAL CAP ASSEMBLY W/ACCESSORIES, MODEL SSL3P, EES FIXED- LENGTH ACCESS RETRACTORSK082278MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERSK080972ECHELON ZEBRA CARTRIDGES, MODELS, Z45WB, Z45BG, Z45GP, Z60WB, Z60BG, ZP60GP

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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