Suture-TOOL System— 510(k) K250977

Substantially Equivalent

Suturion AB

FDA 510(k) clearance K250977 for Suture-TOOL System, Substantially Equivalent on 2025-04-28. Applicant: Suturion AB.

Clearance details

Applicant: Suturion AB
Product code: Code NEW
Advisory panel: General, Plastic Surgery
Date received: 2025-03-31
Decision date: 2025-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Lund, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEW

product code NEW

Death: 32
Injury: 2,179
Malfunction: 8,975
Total: 11,186

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.