GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4— 510(k) K092278

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K092278 for GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4, Substantially Equivalent on 2009-09-29. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code HIH
Advisory panel: Obstetrics/Gynecology
Date received: 2009-07-28
Decision date: 2009-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

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Adverse events under product code HIH

product code HIH

Death: 18
Injury: 973
Malfunction: 5,071
Other: 1
Total: 6,063

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.