# K160754: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)

- Pathway: 510(k) (Traditional)
- Applicant: Venclose, Inc.
- Decided: Sep 9, 2016 after 175 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K943450 (1995). 25 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040638: Vnus Radiofrequency Generator, Model RFG2, Vnus Medical Technologies, Inc. (2004) Summary page 4.
- K061373: Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100, Vnus Medical Technologies, Inc. (2006) Summary page 4.

## Most influential descendants
- K211806: Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter (2021), 2 descendants of its own
- K250068: Venclose digiRF Generator (VCRFG1) (2025), 1 descendant of its own
- 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
- Sep 4, 2024 · Class II · Z-0371-2025: The Venclose" RF Ablation Catheters may have been manufactured with internal wiring error. The red and yellow signal wires were soldered on swapped ports of the catheter PCB. This error in wire config

## Indications for use
The Venclose™ Radiofrequency System (Generator and Catheters) is intended for use in endovascular coagulation of blood vessels in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K160754
Methodology: https://510kreport.com/methodology