# K990723: Dyonics Varicose Vein Ablation Blade

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Oct 5, 1999 after 214 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 4 (0 Class I)
- 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 its predicate without a number.
- (no number) Medicon Ambulatory Phlebectomy Hook: named in the summary without a submission number

## Most influential descendants
- K032387: Trivex System (2003), 1 descendant of its own
- K212894: PhasTIPP (2022), 0 descendants of its own

## Recalls of this device
- Jun 19, 2006 · Not classified · Z-1229-06: The sterility seal of the package trays may have incomplete seals compromising the sterility of the device
- Jun 19, 2006 · Not classified · Z-1227-06: The sterility seal of the package trays may have incomplete seals compromising the sterility of the device
- Jun 19, 2006 · Not classified · Z-1226-06: The sterility seal of the package trays may have incomplete seals compromising the sterility of the device
- Jun 19, 2006 · Not classified · Z-1228-06: The sterility seal of the package trays may have incomplete seals compromising the sterility of the device

## Indications for use
The Dyonics Varicose Vein Ablation Blade (proprietary name TBD) is indicated for use in ambulatory phlebectomy procedures for the resection and ablation of varicose veins.

Source page: https://510kreport.com/device/K990723
Methodology: https://510kreport.com/methodology