FDA 510(k)

Kohli Urinary Drainage Catheter

Número K: K172422 · 2018-02-09

Data da decisão2018-02-09

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Kohli Urinary Drainage Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nellie Medical, LLC. It received FDA 510(k) clearance on 2018-02-09 under 510(k) number K172422. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Kohli Urinary Drainage Catheter?

Kohli Urinary Drainage Catheter is a medical device that received FDA 510(k) clearance on 2018-02-09. The listed applicant is Nellie Medical, LLC. The 510(k) number is K172422.

When did Kohli Urinary Drainage Catheter receive FDA 510(k) clearance?

Kohli Urinary Drainage Catheter received FDA 510(k) clearance on 2018-02-09, under 510(k) number K172422.

Who is the listed applicant for Kohli Urinary Drainage Catheter?

The FDA 510(k) record lists Nellie Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kohli Urinary Drainage Catheter?

The FDA product code for Kohli Urinary Drainage Catheter is EZL.

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