FDA 510(k)

Disposable Sphincterotome

N.º K: K232476 · 2023-11-07

SolicitanteZhejiang Soudon Medical Technology Co., Ltd.

Fecha de decisión2023-11-07

Código de productoKNS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Disposable Sphincterotome is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-07 under 510(k) number K232476. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Disposable Sphincterotome?

Disposable Sphincterotome is a medical device that received FDA 510(k) clearance on 2023-11-07. The listed applicant is Zhejiang Soudon Medical Technology Co., Ltd.. The 510(k) number is K232476.

When did Disposable Sphincterotome receive FDA 510(k) clearance?

Disposable Sphincterotome received FDA 510(k) clearance on 2023-11-07, under 510(k) number K232476.

Who is the listed applicant for Disposable Sphincterotome?

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

What is the FDA product code for Disposable Sphincterotome?

The FDA product code for Disposable Sphincterotome is KNS.

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

K253013Disposable Stone Retrieval Balloon Catheter K253056Disposable Stone Extraction Basket K232450Disposable Hemostatic Clips K232442Disposable Endoscope Injection Needles

Dispositivos relacionados (Código: KNS)

K262460Rezum SystemBoston Scientific K260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems Corporation K250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

Fuente oficial

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