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FDA 510(k)

Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)

N.º K: K250688 · 2025-10-07

SolicitanteAcotec Scientific Co., Ltd.
Fecha de decisión2025-10-07
Código de productoGEI
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) is the device name listed in this FDA 510(k) record. The listed applicant is Acotec Scientific Co., Ltd.. It received FDA 510(k) clearance on 2025-10-07 under 510(k) number K250688. 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 Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)?

Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) is a medical device that received FDA 510(k) clearance on 2025-10-07. The listed applicant is Acotec Scientific Co., Ltd.. The 510(k) number is K250688.

When did Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) receive FDA 510(k) clearance?

Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) received FDA 510(k) clearance on 2025-10-07, under 510(k) number K250688.

Who is the listed applicant for Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)?

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

What is the FDA product code for Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)?

The FDA product code for Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US) is GEI.

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Fuente oficial

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