FDA 510(k)

Cáteter de Tracção de Silicone 100% Duplo

Número K: K222118 · 2022-12-01

Data da decisão2022-12-01

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

2-Way 100% Silicone Cleartract Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Silq Technologies, Corp.. It received FDA 510(k) clearance on 2022-12-01 under 510(k) number K222118. 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 2-Way 100% Silicone Cleartract Catheter?

2-Way 100% Silicone Cleartract Catheter is a medical device that received FDA 510(k) clearance on 2022-12-01. The listed applicant is Silq Technologies, Corp.. The 510(k) number is K222118.

When did 2-Way 100% Silicone Cleartract Catheter receive FDA 510(k) clearance?

2-Way 100% Silicone Cleartract Catheter received FDA 510(k) clearance on 2022-12-01, under 510(k) number K222118.

Who is the listed applicant for 2-Way 100% Silicone Cleartract Catheter?

The FDA 510(k) record lists Silq Technologies, Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2-Way 100% Silicone Cleartract Catheter?

The FDA product code for 2-Way 100% Silicone Cleartract Catheter is EZL.

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