FDA 510(k)

Single Use Ureteral Access Sheath

N.º K: K260410 · 2026-09-11

SolicitanteZhejiang Chuangxiang Medical Technology Co., Ltd.

Fecha de decisión2026-09-11

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 2026-09-11 under 510(k) number K260410. 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 2026-09-11. The listed applicant is Zhejiang Chuangxiang Medical Technology Co., Ltd.. The 510(k) number is K260410.

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

Single Use Ureteral Access Sheath received FDA 510(k) clearance on 2026-09-11, under 510(k) number K260410.

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

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Dispositivos relacionados (Código: FED)

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.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.K252572Prodeon Urethral Sheath SystemProdeon Medical, Inc.

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.