FDA 510(k)

EndoChoice Select Injection Needle

Número K: K151475 · 2016-02-08

Data da decisão2016-02-08

Código do produtoFBK

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

EndoChoice Select Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Endochoice, Inc.. It received FDA 510(k) clearance on 2016-02-08 under 510(k) number K151475. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the EndoChoice Select Injection Needle?

EndoChoice Select Injection Needle is a medical device that received FDA 510(k) clearance on 2016-02-08. The listed applicant is Endochoice, Inc.. The 510(k) number is K151475.

When did EndoChoice Select Injection Needle receive FDA 510(k) clearance?

EndoChoice Select Injection Needle received FDA 510(k) clearance on 2016-02-08, under 510(k) number K151475.

Who is the listed applicant for EndoChoice Select Injection Needle?

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

What is the FDA product code for EndoChoice Select Injection Needle?

The FDA product code for EndoChoice Select Injection Needle is FBK.

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Outros registros que listam Endochoice, Inc. como candidato(a)

K160275Fuse Endoscopic System with FuseBox Processor K161482EndoChoice Water Bottle Cap Irrigation System K161167Seal Single-Use Biopsy Valve K160403SmartStart Air/Water and Suction Valves K153588EndoChoice Water Bottle Cap System

Dispositivos Relacionados (Código: FBK)

K260262Injection NeedleMirco-Tech (Nanjing) Co., Ltd.K253598InjecSURE Injection SystemCarbon Medical Technologies, Inc.K252021Disposable Endoscopic Injection NeedlesChangzhou New Med Micro-Medtech Co., Ltd.K252247Injector Force Max Single Use Injector (NM-400L); Injector Force Max Single Use Injector (NM-400U); Injector Force Max Single Use Injector (NM-400Y); Injector Force Max Single Use Injector (NM-401L)Olympus Medical Systems Corporation K241595EzVu Visual Vasopressor injector (EV-19)Veol Medical Technologies Pvt , Ltd.K240675Endoscopic Injection NeedlesPromisemed Hangzhou Meditech Co., Ltd.

Fonte oficial

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