ACMI VISTA CTR BIPOLAR LOOP ELECTRODE— 510(k) K031001

Substantially Equivalent

Acmi Corporation

FDA 510(k) clearance K031001 for ACMI VISTA CTR BIPOLAR LOOP ELECTRODE, Substantially Equivalent on 2003-05-21. Applicant: Acmi Corporation.

Clearance details

Applicant: Acmi Corporation
Product code: Code FAS
Advisory panel: Gastroenterology, Urology
Date received: 2003-03-31
Decision date: 2003-05-21
Decision: Substantially Equivalent
Clearance type: Special
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.