GYRUS ACMI PK BUTTON ELECTRODE— 510(k) K093181

Clearance details

Applicant

Gyrus Acmi, Inc.

Product code

Code FAS

Device class

Class 2

Regulation

21 CFR 876.4300

Advisory panel

Gastroenterology, Urology

Date received

2009-10-08

Decision date

2010-02-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Southborough, MA, US

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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 →