FDA 510(k)

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

N.º K: K192339 · 2020-01-30

Fecha de decisión2020-01-30

Código de productoKNS

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K192339. 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 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord?

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K192339.

When did TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord receive FDA 510(k) clearance?

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord received FDA 510(k) clearance on 2020-01-30, under 510(k) number K192339.

Who is the listed applicant for TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord?

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

What is the FDA product code for TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord?

The FDA product code for TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord is KNS.

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Otros registros que enlistan a Wilson-Cook Medical, Inc. como solicitante

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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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