# K252316: Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

- Pathway: 510(k) (Special)
- Applicant: Venclose, Inc.
- Decided: Aug 19, 2025 after 25 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: 12 generations back to K943450 (1995). 37 ancestors in all.
No later device cites it as a predicate yet.
0 of 38 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160754: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter), Venclose, Inc. (2016) Summary page 5.
- K250068: Venclose digiRF Generator (VCRFG1), Venclose, Inc. (2025) Summary page 5.

## Indications for use
The Venclose System (Venclose digiRF Generator with EVSRF Catheter) is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K252316
Methodology: https://510kreport.com/methodology