USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8— 510(k) K023358

Substantially Equivalent

Acmi Corporation

FDA 510(k) clearance K023358 for USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8, Substantially Equivalent on 2003-01-03. Applicant: Acmi Corporation.

Clearance details

Applicant: Acmi Corporation
Product code: Code FGB
Advisory panel: Gastroenterology, Urology
Date received: 2002-10-07
Decision date: 2003-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

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Adverse events under product code FGB

product code FGB

Death: 6
Injury: 552
Malfunction: 3,922
Other: 1
Total: 4,481

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.