# K032387: Trivex System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 29, 2003 after 86 days
- Product code: DWQ (Stripper, Vein, External)
- Device class: 2
- Regulation: 21 CFR 870.4885
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K964561 (1997). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990723: Dyonics Varicose Vein Ablation Blade, Smith & Nephew, Inc. (1999) Summary page 1.
- K991323: Smith & Nephew Subcutaneous Illuminator, Smith & Nephew, Inc. (1999) Summary page 1.
- K994084: Smith & Nephew Xenon Light Sources and Accessories, Smith & Nephew, Inc. (2000) Summary page 1.

## Cited in the summary but kept off the family tree
- K012044: BI-Phasic Infiltrator, Reliance Medical Corp. (2001). Our reading of the summary gave K012044, FDA’s number for BI-Phasic Infiltrator (Reliance Medical Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “H.K. Surgical Klein Pump”. Kept off the family tree.

## Most influential descendants
- K212894: PhasTIPP (2022), 0 descendants of its own

## Recalls of this device
- Oct 12, 2004 · Not classified · Z-1105-2007: Build-up of static charge in Pneumatic Footswitch tubing may cause control unit to reset to default settings in the operating room during surgery.

## Indications for use
Indicated for use in ambulatory phlebectomy procedures for resection and ablation of varicose veins.

Source page: https://510kreport.com/device/K032387
Methodology: https://510kreport.com/methodology