# K241070: Gelsoft™ Plus Vascular Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Nov 15, 2024 after 210 days
- Product code: DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter)
- Device class: 2
- Regulation: 21 CFR 870.3450
- 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 P890045 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162803: Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts, Vascutek, Ltd. (2017) Summary page 5.

## Recalls of this device
- Dec 18, 2025 · Class II · Z-1492-2026: Gelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life. Device expiry should have been calculated from gel imp

## Indications for use
Gelsoft™ Plus Vascular Prostheses are indicated exclusively for vascular repair of damaged and diseased vessels of the abdomen, i.e. replacement or bypass in aneurysmal and occlusive disease of abdominal arteries.

Source page: https://510kreport.com/device/K241070
Methodology: https://510kreport.com/methodology