# K241550: Gelweave™ Vascular Prostheses

- Pathway: 510(k) (Traditional)
- Applicant: Vascutek, Ltd.
- Decided: Feb 27, 2025 after 272 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: 3 generations back to K952293 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162794: Gelweave 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
Gelweave Vascular Prosthesis (with the exception of Valsalva variant) are indicated for the repair or replacement of damaged and diseased vessels of the thoracic and abdominal aorta in cases of aneurysm, dissection or occlusive disease. Branched configurations can also be used for debranching, i.e. reconstruction of the aortic vessels and associated Hybrid procedures. Hybrid procedures are defined as a treatment combination employing open surgical debranching with endovascular aortic repair. Gelweave Valsalva Vascular Prosthesis are indicated for the repair or replacement of damaged and diseased thoracic aorta, such as aortic root replacement in cases of aneurysm or dissection.

Source page: https://510kreport.com/device/K241550
Methodology: https://510kreport.com/methodology