FDA 510(k)

RocaTub Ureteral Catheter

Número K: K192183 · 2020-04-23

Data da decisão2020-04-23

Código do produtoEYB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RocaTub Ureteral Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Promepal Sam. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K192183. The device is classified under product code EYB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RocaTub Ureteral Catheter?

RocaTub Ureteral Catheter is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Promepal Sam. The 510(k) number is K192183.

When did RocaTub Ureteral Catheter receive FDA 510(k) clearance?

RocaTub Ureteral Catheter received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192183.

Who is the listed applicant for RocaTub Ureteral Catheter?

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

What is the FDA product code for RocaTub Ureteral Catheter?

The FDA product code for RocaTub Ureteral Catheter is EYB.

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