DOLPHIN 3 FLUID MANAGEMENT SYSTEM— 510(k) K110852

Substantially Equivalent

Gyrus Acmi, Inc.

FDA 510(k) clearance K110852 for DOLPHIN 3 FLUID MANAGEMENT SYSTEM, Substantially Equivalent on 2011-07-19. Applicant: Gyrus Acmi, Inc..

Clearance details

Applicant: Gyrus Acmi, Inc.
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2011-03-28
Decision date: 2011-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southborough, MA, US

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Adverse events under product code HIG

product code HIG

Death: 8
Other: 2
Total: 10

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.