Multi4 System— 510(k) K250522

Substantially Equivalent

Multi4 Medical AB

FDA 510(k) clearance K250522 for Multi4 System, Substantially Equivalent on 2025-06-27. Applicant: Multi4 Medical AB.

Clearance details

Applicant: Multi4 Medical AB
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2025-02-21
Decision date: 2025-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jönköping, SE

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.