FDA 510(k)

Wiygul Catheter

Número K: K202566 · 2020-09-30

Data da decisão2020-09-30

Código do produtoEZD

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Wiygul Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Big Blue Biotech, Inc.. It received FDA 510(k) clearance on 2020-09-30 under 510(k) number K202566. The device is classified under product code EZD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Wiygul Catheter?

Wiygul Catheter is a medical device that received FDA 510(k) clearance on 2020-09-30. The listed applicant is Big Blue Biotech, Inc.. The 510(k) number is K202566.

When did Wiygul Catheter receive FDA 510(k) clearance?

Wiygul Catheter received FDA 510(k) clearance on 2020-09-30, under 510(k) number K202566.

Who is the listed applicant for Wiygul Catheter?

The FDA 510(k) record lists Big Blue Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Wiygul Catheter?

The FDA product code for Wiygul Catheter is EZD.

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