# Suturion AB

- Location (FDA's records): Lund, SE
- FDA decisions: 2 (2025–2025): 2 510(k) clearances
- Product codes: NEW (2)
- Predicates its devices cite: 2 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Assut Europe S.P.A.: 1 (https://510kreport.com/company/assut-europe)

## Its most-cited devices
- K242835: Suture-TOOL System (2025), cited by 1

## Recent decisions
- K250977: Suture-TOOL System (Apr 28, 2025)
- K242835: Suture-TOOL System (Jan 22, 2025)

Source page: https://510kreport.com/company/suturion