DUOSTAR— 510(k) K974170

Substantially Equivalent

Mti Corp./ Electrostar S.A.-Haiti

FDA 510(k) clearance K974170 for DUOSTAR, Substantially Equivalent on 1998-09-30. Applicant: Mti Corp./ Electrostar S.A.-Haiti.

Clearance details

Applicant: Mti Corp./ Electrostar S.A.-Haiti
Product code: Code GEI
Advisory panel: General, Plastic Surgery
Date received: 1997-11-05
Decision date: 1998-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Safety Harbor, FL, US

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.