FDA 510(k)

Silicone Urethral Catheter (Silicone Urethral Catheter)

N.º K: K243011 · 2025-06-16

SolicitanteGuangdong Ecan Medical Co., Ltd.

Fecha de decisión2025-06-16

Código de productoEZL

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Fuente oficial

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