FDA 510(k)

Disposable Endoscope Injection Needle

N.º K: K220292 · 2022-08-19

SolicitanteYangzhou Fartley Medical Instrument Technology Co., Ltd.

Fecha de decisión2022-08-19

Código de productoFBK

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Endoscope Injection Needle is the device name listed in this FDA 510(k) record. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K220292. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Endoscope Injection Needle?

Disposable Endoscope Injection Needle is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Yangzhou Fartley Medical Instrument Technology Co., Ltd.. The 510(k) number is K220292.

When did Disposable Endoscope Injection Needle receive FDA 510(k) clearance?

Disposable Endoscope Injection Needle received FDA 510(k) clearance on 2022-08-19, under 510(k) number K220292.

Who is the listed applicant for Disposable Endoscope Injection Needle?

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

What is the FDA product code for Disposable Endoscope Injection Needle?

The FDA product code for Disposable Endoscope Injection Needle is FBK.

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Otros registros que enlistan a Yangzhou Fartley Medical Instrument Technology Co., Ltd. como solicitante

K260512Disposable Ureteral Access Sheath K260423Disposable Endoscopic Distal Attachments K250732Disposable Endoscopy Valve Set K230004Disposable Hemoclip K222980Pentax Medical Valve Set K220785Clean Connecting Tube

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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.

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.