FDA 510(k)

Silicone Foley Catheter

Número K: K182463 · 2019-11-06

RequerenteBiosensors International Pte, Ltd.

Data da decisão2019-11-06

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Silicone Foley Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Biosensors International Pte, Ltd.. It received FDA 510(k) clearance on 2019-11-06 under 510(k) number K182463. 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 Silicone Foley Catheter?

Silicone Foley Catheter is a medical device that received FDA 510(k) clearance on 2019-11-06. The listed applicant is Biosensors International Pte, Ltd.. The 510(k) number is K182463.

When did Silicone Foley Catheter receive FDA 510(k) clearance?

Silicone Foley Catheter received FDA 510(k) clearance on 2019-11-06, under 510(k) number K182463.

Who is the listed applicant for Silicone Foley Catheter?

The FDA 510(k) record lists Biosensors International Pte, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silicone Foley Catheter?

The FDA product code for Silicone Foley Catheter is EZL.

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