GYRUS ACMI PK BUTTON ELECTRODE— 510(k) K093181

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K093181 for GYRUS ACMI PK BUTTON ELECTRODE, Substantially Equivalent on 2010-02-24. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2009-10-08
Decision date: 2010-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FAS

product code FAS

Death: 3
Injury: 344
Malfunction: 1,130
Total: 1,477

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.