# K250068: Venclose digiRF Generator (VCRFG1)

- Pathway: 510(k) (Special)
- Applicant: Venclose, Inc.
- Decided: Feb 4, 2025 after 25 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K943450 (1995). 36 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K211806: Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter, Venclose, Inc. (2021) Summary page 5.

## Most influential descendants
- K252316: Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) (2025), 0 descendants of its own

## Recalls of this device
- Aug 21, 2025 · Class II · Z-2638-2025: Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior

## 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. The Venclose Maven System (digiRF Generator and Maven Catheter) is intended for endovascular coagulation of blood vessels in patients with perforator and tributary vein reflux.

Source page: https://510kreport.com/device/K250068
Methodology: https://510kreport.com/methodology