FDA 510(k)

Ureteral Dilator Sets, Ureteral Dilators

Número K: K173654 · 2018-07-17

Data da decisão2018-07-17

Código do produtoEZN

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Ureteral Dilator Sets, Ureteral Dilators is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-07-17 under 510(k) number K173654. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Ureteral Dilator Sets, Ureteral Dilators?

Ureteral Dilator Sets, Ureteral Dilators is a medical device that received FDA 510(k) clearance on 2018-07-17. The listed applicant is Cook Incorporated. The 510(k) number is K173654.

When did Ureteral Dilator Sets, Ureteral Dilators receive FDA 510(k) clearance?

Ureteral Dilator Sets, Ureteral Dilators received FDA 510(k) clearance on 2018-07-17, under 510(k) number K173654.

Who is the listed applicant for Ureteral Dilator Sets, Ureteral Dilators?

The FDA 510(k) record lists Cook Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ureteral Dilator Sets, Ureteral Dilators?

The FDA product code for Ureteral Dilator Sets, Ureteral Dilators is EZN.

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Fonte oficial

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