FDA 510(k)

ECHELON ENDOPATH Staple Line Reinforcement

N.º K: K221343 · 2022-09-16

Fecha de decisión2022-09-16

Código de productoOXC

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ECHELON ENDOPATH Staple Line Reinforcement 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 2022-09-16 under 510(k) number K221343. The device is classified under product code OXC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the ECHELON ENDOPATH Staple Line Reinforcement?

ECHELON ENDOPATH Staple Line Reinforcement is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Ethicon Endo-Surgery, LLC. The 510(k) number is K221343.

When did ECHELON ENDOPATH Staple Line Reinforcement receive FDA 510(k) clearance?

ECHELON ENDOPATH Staple Line Reinforcement received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221343.

Who is the listed applicant for ECHELON ENDOPATH Staple Line Reinforcement?

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 ENDOPATH Staple Line Reinforcement?

The FDA product code for ECHELON ENDOPATH Staple Line Reinforcement is OXC.

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Otros registros que enlistan a Ethicon Endo-Surgery, LLC como solicitante

Ver todos los 35 dispositivos →

Dispositivos relacionados (Código: OXC)

K252906ECHELON ENDOPATH Staple Line Reinforcement (ECH60R)Ethicon Endo-Surgery, LLC K231603Standard Staple-Line Reinforcement (SSLR23)Standard Bariatrics, Inc.K221487NEOVEIL Staple Line ReinforcementGunze Limited K190937Echelon Endopath Staple Line ReinforcementEthicon Endo-Surgery, LLC K181940GORE SEAMGUARD Bioabsorbable Staple Line ReinforcementW. L. Gore & Associates, Inc.

Fuente oficial

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