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FDA 510(k)

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler

Número K: K213633 · 2022-04-08

RequerenteEthicon Endo-Surgery, LLC
Data da decisão2022-04-08
Código do produtoGAG
Comité consultivoHO
DecisãoSubstantially Equivalent

Resumo do dispositivo

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler 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 2022-04-08 under 510(k) number K213633. The device is classified under product code GAG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler?

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler is a medical device that received FDA 510(k) clearance on 2022-04-08. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K213633.

When did ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler receive FDA 510(k) clearance?

ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler received FDA 510(k) clearance on 2022-04-08, under 510(k) number K213633.

Who is the listed applicant for ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler?

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 ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler?

The FDA product code for ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler is GAG.

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Outros registros que listam Ethicon Endo-Surgery, LLC como candidato(a)

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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)

Ver todos os 35 dispositivos →

Dispositivos Relacionados (Código: GAG)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K253527Tri-Staple™ 2.0 Black Circular Reload 21mm Extra Thick (SIGCIR21XT); Tri-Staple™ 2.0 Black Circular Reload 25mm Extra Thick (SIGCIR25XT)Covidien, LLCK251482AEON® Endoscopic Powered StaplerLexington Medical, Inc.K243596da Vinci SP SureForm 45 Staplers and Reloads (SP1098)Intuitive Surgical, Inc.K240881Signia™ Circular Adapter (Standard Length) (SIGCIRSTND); Signia™ Circular Adapter XL Length (SIGCIRXL)Covidien (Part of Medtronic)K241629ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (ECH45S); Echelon 3000 45mm Long Stapler (ECH45L); Echelon 3000 60mm Compact Stapler (ECH60C); Echelon 3000 60mm Standard Stapler (ECH60S); Echelon 3000 60mm Long Stapler (ECH60L)Ethicon Endo-Surgery, LLCK234039AEON Endoscopic Powered Stapler (Curto/AEPH060); AEON Endoscopic Powered Stapler (Médio/AEPH160); AEON Endoscopic Powered Stapler (Longo/AEPH260)Lexington Medical, Inc.

Fonte oficial

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