# K221280: Vesseal

- Pathway: 510(k) (Traditional)
- Applicant: Lydus Medical, Ltd.
- Decided: Dec 9, 2022 after 220 days
- Product code: GAW (Suture, Nonabsorbable, Synthetic, Polypropylene)
- Device class: 2
- Regulation: 21 CFR 878.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K954808 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192420: Crownjun Nylon Suture, Kono Seisakusho Co., Ltd. (2020) Summary page 4.
- K013683: Modification to: Abbott Vascular Suture Anastomosis Device, Abbott Vascular, Inc. (2001) Summary page 4.

## Indications for use
The Vesseal is intended for use in the delivery of 8 interrupted sutures to assist the surgeon in the creation of a vascular anastomosis in arteries of 2-4mm in diameter. It is not intended for use in coronary artery grafts.

Source page: https://510kreport.com/device/K221280
Methodology: https://510kreport.com/methodology