DUET-V (Model: ESK-3261DV)— 510(k) K233118

Substantially Equivalent

Eunsung Global Corp

FDA 510(k) clearance K233118 for DUET-V (Model: ESK-3261DV), Substantially Equivalent on 2025-01-03. Applicant: Eunsung Global Corp.

Clearance details

Applicant: Eunsung Global Corp
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 2023-09-27
Decision date: 2025-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wonju-Si, KR

Download summary PDF View on FDA.gov ↗

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.