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FDA 510(k)

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads

N.º K: K182476 · 2019-12-18

SolicitanteFengh Medical Co., Ltd.
Fecha de decisión2019-12-18
Código de productoGDW
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is the device name listed in this FDA 510(k) record. The listed applicant is Fengh Medical Co., Ltd.. It received FDA 510(k) clearance on 2019-12-18 under 510(k) number K182476. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is a medical device that received FDA 510(k) clearance on 2019-12-18. The listed applicant is Fengh Medical Co., Ltd.. The 510(k) number is K182476.

When did Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads receive FDA 510(k) clearance?

Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads received FDA 510(k) clearance on 2019-12-18, under 510(k) number K182476.

Who is the listed applicant for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

The FDA 510(k) record lists Fengh Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads?

The FDA product code for Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads is GDW.

Ensayos clínicos relacionados

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Otros registros que enlistan a Fengh Medical Co., Ltd. como solicitante

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K242679Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series)K202467Disposable Powered Articulating Endoscopic Linear Cutter Stapler & ReloadsK180208Disposable Endoscopic Trocar

Dispositivos relacionados (Código: GDW)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

K254291easyEndo™ E-Lite Single Use Powered Endoscopic Staplers; easyEndo™ E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo™ E-Lite Single Use CartridgesEzisurg Medical Co., Ltd.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)Ethicon Endo-Surgery, LLCK253657Tri-staple 2.0™ Reloads; Endo GIA™ Reloads with Tri-Staple™ Technology; Endo GIA™ Gray Articulating Reloads; Signia™ Small Diameter ReloadsCovidien (Part of Medtronic)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)Ethicon Endo-Surgery, LLCK250835ETHICON 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)Ethicon Endo-Surgery, LLCK243276ECHELON 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)Ethicon Endo-Surgery, LLC

Fuente oficial

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