# K250688: Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US); Cedar™ Endovenous Radiofrequency Catheter (ERA-C30-US); Endovenous Radiofrequency Generator (ERA-G5-US)

- Pathway: 510(k) (Traditional)
- Applicant: Acotec Scientific Co., Ltd.
- Decided: Oct 7, 2025 after 215 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943450 (1995). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111887: Closurefast Radiofrequency Catheter, Covidien (2011) Summary page 5.
- K141858: Closurerfg Radiofrequency Generator, Covidien (2014) Summary page 5.

## Indications for use
Cedar-T Endovenous Radiofrequency Catheters are intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. The Endovenous Radiofrequency Generator is used with radiofrequency catheters intended for vessel coagulation.

Source page: https://510kreport.com/device/K250688
Methodology: https://510kreport.com/methodology