# K250977: Suture-TOOL System

- Pathway: 510(k) (Special)
- Applicant: Suturion AB
- Decided: Apr 28, 2025 after 28 days
- Product code: NEW (Suture, Surgical, Absorbable, Polydioxanone)
- Device class: 2
- Regulation: 21 CFR 878.4840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K141776 (2014). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242835: Suture-TOOL System, Suturion AB (2025) Summary page 5.

## Indications for use
The Suture-TOOL System is intended for abdominal wall closure after laparotomy in patients 18 years old and older.

Source page: https://510kreport.com/device/K250977
Methodology: https://510kreport.com/methodology