FDA 510(k)

Silicone Urethral Catheter (Silicone Urethral Catheter)

Número K: K243011 · 2025-06-16

RequerenteGuangdong Ecan Medical Co., Ltd.

Data da decisão2025-06-16

Código do produtoEZL

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Silicone Urethral Catheter (Silicone Urethral Catheter) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Ecan Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-06-16 under 510(k) number K243011. 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 Urethral Catheter (Silicone Urethral Catheter)?

Silicone Urethral Catheter (Silicone Urethral Catheter) is a medical device that received FDA 510(k) clearance on 2025-06-16. The listed applicant is Guangdong Ecan Medical Co., Ltd.. The 510(k) number is K243011.

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

Silicone Urethral Catheter (Silicone Urethral Catheter) received FDA 510(k) clearance on 2025-06-16, under 510(k) number K243011.

Who is the listed applicant for Silicone Urethral Catheter (Silicone Urethral Catheter)?

The FDA 510(k) record lists Guangdong Ecan Medical Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silicone Urethral Catheter (Silicone Urethral Catheter)?

The FDA product code for Silicone Urethral Catheter (Silicone Urethral Catheter) is EZL.

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