FDA 510(k)

Evolution Esophageal Stent System – Partially Covered

N.º K: K162717 · 2016-12-21

Fecha de decisión2016-12-21

Código de productoESW

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Evolution Esophageal Stent System – Partially Covered is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K162717. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Evolution Esophageal Stent System – Partially Covered?

Evolution Esophageal Stent System – Partially Covered is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K162717.

When did Evolution Esophageal Stent System – Partially Covered receive FDA 510(k) clearance?

Evolution Esophageal Stent System – Partially Covered received FDA 510(k) clearance on 2016-12-21, under 510(k) number K162717.

Who is the listed applicant for Evolution Esophageal Stent System – Partially Covered?

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

What is the FDA product code for Evolution Esophageal Stent System – Partially Covered?

The FDA product code for Evolution Esophageal Stent System – Partially Covered is ESW.

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Otros registros que enlistan a Cook Ireland, Ltd. como solicitante

K261274EchoTip Ultra® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes; EchoTip ProCore® Endobronchial HD Ultrasound Biopsy Needle for Fujifilm Scopes K241209EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19)K233079Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS); Geenen® Pancreatic Stents/Stent Sets (GEPD, GPDS, GPSO, GPSOS); Johlin® Pancreatic Wedge Stent and Introducer Set (JPWS); Pushing Catheter and Guiding Catheter (GC, PC); Geenen® Sof-Flex® Pancreatic Stent (GPSO-SF. GPSOS-SF)K230909EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22)K213946Compass BDS Biliary Stent K210476EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle

Ver todos los 16 dispositivos →

Dispositivos relacionados (Código: ESW)

K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd.K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd.K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc.K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific K233837Agile Esophageal Stent SystemBoston Scientific Corporation

Fuente oficial

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