# K100199: Angiodynamics, Inc., Percutaneous Introducer and Venacureevlt Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Nov 26, 2010 after 308 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
No predicates in its family tree.
2 later devices descend 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K133561: Venacure Evlt Nevertouch Procedure Kit, Venacure Evlt Tre' Sheath (2013), 1 descendant of its own
- K142614: AngioDynamics VenaCure EVLT Tre’ Sheath and VenaCure EVLT NeverTouch Procedure Kits (2014), 0 descendants of its own

## Indications for use
The AngioDynamics, Inc. VenaCureEVLT Procedure Kit with Percutaneous Introducer is 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 refiux of superficial veins of the lower extremity. The AngioDynamics, Inc. VenaCureEVLT Procedure Kit is indicated for use with 810 nn and 980 rim Diode Lasers with SMA 905 connectors.

Source page: https://510kreport.com/device/K100199
Methodology: https://510kreport.com/methodology