K250688

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

510(k) number
K250688
Device name
Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)
Applicant
Acotec Scientific Co., Ltd. CN
Product code
GEI — Electrosurgical, Cutting & Coagulation & Accessories
Decision date
2025-10-07
Date received
2025-03-06
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain

Also available from FDA: K250688.pdf

Official FDA record: K250688
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.