K250217

Substantially Equivalent

AGNES Ultra

Applicant: Agnes Medical Co., Ltd.
Product code: GEI
Advisory panel: General, Plastic Surgery
Date received: 2025-01-24
Decision date: 2025-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seongnam-Si, KR

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.