FDA 510(k)

Single Use Ureteral Access Sheath

N.º K: K220065 · 2022-05-25

SolicitanteZhejiang Chuangxiang Medical Technology Co., Ltd.

Fecha de decisión2022-05-25

Código de productoFED

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Single Use Ureteral Access Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K220065. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Single Use Ureteral Access Sheath?

Single Use Ureteral Access Sheath is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K220065.

When did Single Use Ureteral Access Sheath receive FDA 510(k) clearance?

Single Use Ureteral Access Sheath received FDA 510(k) clearance on 2022-05-25, under 510(k) number K220065.

Who is the listed applicant for Single Use Ureteral Access Sheath?

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

What is the FDA product code for Single Use Ureteral Access Sheath?

The FDA product code for Single Use Ureteral Access Sheath is FED.

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Otros registros que enlistan a Zhejiang Chuangxiang Medical Technology Co., Ltd. como solicitante

K260410Single Use Ureteral Access Sheath K253132Single use stone retrieval balloons K251890Disposable Ureteral Stents K230773Endoscopy Irrigation Tubing K231471Tubo de botella de aire/agua, tubo de fuente de CO2 K220063Single Use Cytology Brush

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Dispositivos relacionados (Código: FED)

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific Corporation K260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

Fuente oficial

Ver en la base de datos de la FDA →

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