# K040638: Vnus Radiofrequency Generator, Model RFG2

- Pathway: 510(k) (Traditional)
- Applicant: Vnus Medical Technologies, Inc.
- Decided: Jun 7, 2004 after 89 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: 8 generations back to K943450 (1995). 23 ancestors in all.
10 later devices descend from it; 5 cite it directly.
0 of 34 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.

## Cited in the summary but kept off the family tree
- K003354: VNUS Vessel and Tissue System. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K160754: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) (2016), 3 descendants of its own
- K211806: Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter (2021), 2 descendants of its own
- K141858: Closurerfg Radiofrequency Generator (2014), 2 descendants of its own
- K250068: Venclose digiRF Generator (VCRFG1) (2025), 1 descendant of its own
- K253918: Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) (2026), 0 descendants of its own

## Indications for use
The VNUS Radiofrequency Generator is intended for use with VNUS radiofrequency devices intended for vessel and tissue coagulation.

Source page: https://510kreport.com/device/K040638
Methodology: https://510kreport.com/methodology