FDA 510(k)

TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord

Número K: K192339 · 2020-01-30

Data da decisão2020-01-30

Código do produtoKNS

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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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Dispositivos Relacionados (Código: KNS)

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Fonte oficial

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