# K171921: VenaCure EVLT NeverTouch Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Aug 24, 2017 after 58 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 K162914 (2016). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162914: VenaCure EVLT NeverTouch Procedure Kit, AngioDynamics, Inc. (2016) Summary page 4.

## Most influential descendants
- K231945: VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits (2023), 0 descendants of its own

## Indications for use
The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

Source page: https://510kreport.com/device/K171921
Methodology: https://510kreport.com/methodology