MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565— 510(k) K090814

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K090814 for MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565, Substantially Equivalent on 2009-04-20. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code FAJ
Advisory panel: Gastroenterology, Urology
Date received: 2009-03-25
Decision date: 2009-04-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Southborough, MA, US

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Adverse events under product code FAJ

product code FAJ

Injury: 533
Malfunction: 6,705
Total: 7,238

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.