# K130671: Venacure Evlt Nevertouch Procedure Kit

- Pathway: 510(k) (Special)
- Applicant: AngioDynamics, Inc.
- Decided: Mar 26, 2013 after 14 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K112600 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112600: Angiodynamics, Inc. Venacure Nevertouch Direct Procedure Kit, AngioDynamics, Inc. (2012)

## Indications for use
The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kit is indicated for endovascular coagulation of the great saphenous vein in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the great saphenous vein, and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Source page: https://510kreport.com/device/K130671
Methodology: https://510kreport.com/methodology