# K211806: Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Venclose, Inc.
- Decided: Aug 3, 2021 after 53 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: 10 generations back to K943450 (1995). 35 ancestors in all.
2 later devices descend 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)
- K052003: Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX = 10, 20, 30 & 40), Vnus Medical Technologies, Inc. (2005) Summary page 4.
- K160754: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter), Venclose, Inc. (2016) Summary page 4.

## Most influential descendants
- 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

## Indications for use
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/K211806
Methodology: https://510kreport.com/methodology