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FDA 510(k)

ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS

K-Number: K123212 · 2013-03-08

ApplicantEthicon Endo-Surgery, LLC
Decision Date2013-03-08
Product CodePDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS 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 2013-03-08 under 510(k) number K123212. The device is classified under product code PDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS?

ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS is a medical device that received FDA 510(k) clearance on 2013-03-08. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K123212.

When did ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS receive FDA 510(k) clearance?

ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS received FDA 510(k) clearance on 2013-03-08, under 510(k) number K123212.

Who is the listed applicant for ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS?

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 ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS?

The FDA product code for ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS is PDG.

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Other records listing Ethicon Endo-Surgery, 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.

K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)K260196ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICON™ Circular Stapler (CDH29mm); ETHICON™ Circular Stapler (CDH33mm); ETHICON™ Circular Stapler - XL Sealed (ECS21mm); ETHICON™ Circular Stapler - XL Sealed (ECS25mm); ETHICON™ Circular Stapler - XL Sealed (ECS29mm); ETHICON™ Circular Stapler - XL Sealed (ECS33mm)K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)K252739ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapler (EC3DT45S); ETHICON™ 4000 45mm Long Stapler (EC3DT45L); ETHICON™ 3D 45mm White Reload (ER45W); ETHICON™ 3D 45mm Blue Reload (ER45B); ETHICON™ 3D 45mm Green Reload (ER45G); ETHICON™ 3D 45mm Black Reload (ER45T)K250835ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (EC3D60S); ETHICON 4000 60mm Long Stapler (EC3D60L); ETHICON 3D 60mm White Reload (ER60W); ETHICON 3D 60mm Blue Reload (ER60B); ETHICON 3D 60mm Green Reload (ER60G); ETHICON 3D 60mm Black Reload (ER60T)K243276ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapler (GTX60); ECHELON LINEAR™ Stapler 90mm Stapler (GTX90); ECHELON LINEAR™ Stapler 3D 30mm Blue Reload (GTXR30B); ECHELON LINEAR™ Stapler 3D 30mm Green Reload (GTXR30G); ECHELON LINEAR™ Stapler 3D 60mm Blue Reload (GTXR60B); ECHELON LINEAR™ Stapler 3D 60mm Green Reload (GTXR60G); ECHELON LINEAR™ Stapler 3D 90mm Blue Reload (GTXR90B); ECHELON LINEAR™ Stapler 3D 90mm Green Reload (GTXR90G)

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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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