# K052003: Vnus RFS, Model RFS-6-XX (XX = 10, 12, 13, & 15); Vnus RFS Flex, Model RFX-6-XX (XX = 10, 20, 30 & 40)

- Pathway: 510(k) (Traditional)
- Applicant: Vnus Medical Technologies, Inc.
- Decided: Oct 11, 2005 after 78 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: 9 generations back to K943450 (1995). 31 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982816: Vnus Closure System, Vnus Medical Technologies, Inc. (1999) Summary page 1.
- K003092: Modification to Vnus Closure System, Vnus Medical Technologies, Inc. (2000) Summary page 1.
- K030557: Modification to Vnus Closure System, Vnus Medical Technologies, Inc. (2003) Summary page 1.
- K033547: Vnus Vessel and Tissue Coagulation System, Vnus Medical Technologies, Inc. (2004) Summary page 1.

## 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
- K181044: 400um Perforator and Accessory Vein Ablation Kit (2018), 0 descendants of its own
- K173214: NES Reprocessed RF Stylet (RFS) (2018), 0 descendants of its own

## Indications for use
The VNUS RFS and RFSFlex devices are intended for use in vessel and tissue coagulation including: Treatment of incompetent (i.e., refluxing) perforator and tributary veins

Source page: https://510kreport.com/device/K052003
Methodology: https://510kreport.com/methodology