Sentimag System— 510(k) K222832

Substantially Equivalent

Endomagnetics Ltd.,

FDA 510(k) clearance K222832 for Sentimag System, Substantially Equivalent on 2023-01-21. Applicant: Endomagnetics Ltd.,.

Clearance details

Applicant: Endomagnetics Ltd.,
Product code: Code NEU
Advisory panel: General, Plastic Surgery
Date received: 2022-09-20
Decision date: 2023-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, GB

Download summary PDF View on FDA.gov ↗

Adverse events under product code NEU

product code NEU

Injury: 824
Total: 824

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.