# K031233: Andiodynamics, Inc. Elvs Procedure Kit

- Pathway: 510(k) (Traditional)
- Applicant: AngioDynamics, Inc.
- Decided: Jun 18, 2003 after 62 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The AngioDynamics, Inc. ELVS Procedure Kit is indicated for endovascular coagulation of the greater saphenous vein of the thigh in patients With superficial vein reflux and is also indicated for the troatment of varicose veins and varicosities associated with supcrficial reflux of the greater saphenous vein. The AngioDynamics, Inc. ELVS Proccdure Kit is indicated for use with 810 nm and 980 nm Diode Lasers with SMA 905 connectors.

Source page: https://510kreport.com/device/K031233
Methodology: https://510kreport.com/methodology