FDA 510(k)

Radio Frequency Ablation System

N.º K: K190052 · 2019-06-25

SolicitanteSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.

Fecha de decisión2019-06-25

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Radio Frequency Ablation System is the device name listed in this FDA 510(k) record. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. It received FDA 510(k) clearance on 2019-06-25 under 510(k) number K190052. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Radio Frequency Ablation System?

Radio Frequency Ablation System is a medical device that received FDA 510(k) clearance on 2019-06-25. The listed applicant is Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. The 510(k) number is K190052.

When did Radio Frequency Ablation System receive FDA 510(k) clearance?

Radio Frequency Ablation System received FDA 510(k) clearance on 2019-06-25, under 510(k) number K190052.

Who is the listed applicant for Radio Frequency Ablation System?

The FDA 510(k) record lists Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radio Frequency Ablation System?

The FDA product code for Radio Frequency Ablation System is GEI.

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