FDA 510(k)

Silicone Foley Catheter for single use

N.º K: K172807 · 2018-06-04

SolicitanteChangzhou Rongxin Medicine Minimal Invasion Technology

Fecha de decisión2018-06-04

Código de productoEZL

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Silicone Foley Catheter for single use is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Rongxin Medicine Minimal Invasion Technology. It received FDA 510(k) clearance on 2018-06-04 under 510(k) number K172807. 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 Foley Catheter for single use?

Silicone Foley Catheter for single use is a medical device that received FDA 510(k) clearance on 2018-06-04. The listed applicant is Changzhou Rongxin Medicine Minimal Invasion Technology. The 510(k) number is K172807.

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

Silicone Foley Catheter for single use received FDA 510(k) clearance on 2018-06-04, under 510(k) number K172807.

Who is the listed applicant for Silicone Foley Catheter for single use?

The FDA 510(k) record lists Changzhou Rongxin Medicine Minimal Invasion Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silicone Foley Catheter for single use?

The FDA product code for Silicone Foley Catheter for single use is EZL.

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Fuente oficial

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