FDA 510(k)

United Urologics Intermittent Catheter

Número K: K160795 · 2016-06-16

Data da decisão2016-06-16

Código do produtoGBM

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

United Urologics Intermittent Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Robling Medical. It received FDA 510(k) clearance on 2016-06-16 under 510(k) number K160795. The device is classified under product code GBM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the United Urologics Intermittent Catheter?

United Urologics Intermittent Catheter is a medical device that received FDA 510(k) clearance on 2016-06-16. The listed applicant is Robling Medical. The 510(k) number is K160795.

When did United Urologics Intermittent Catheter receive FDA 510(k) clearance?

United Urologics Intermittent Catheter received FDA 510(k) clearance on 2016-06-16, under 510(k) number K160795.

Who is the listed applicant for United Urologics Intermittent Catheter?

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

What is the FDA product code for United Urologics Intermittent Catheter?

The FDA product code for United Urologics Intermittent Catheter is GBM.

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