# K260105: Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences
- Decided: Jun 5, 2026 after 143 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- 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 K832554 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K832554: Fogarty 6MM Softjaw Clip, American Edwards Laboratories (1983) Summary page 5.

## Indications for use
The Fogarty Spring Clips and Handleless Clamps are indicated for both artery and vein vessel occlusion in adult surgical patient populations. The Fogarty Clamp Inserts are indicated to support the occlusion of veins and arteries without excessive clamping forces for adult patients undergoing surgical procedures.

Source page: https://510kreport.com/device/K260105
Methodology: https://510kreport.com/methodology