AQUILEX FLUID CONTROL SYSTEM H112— 510(k) K112642

Substantially Equivalent

W.O.M. World of Medicine AG

FDA 510(k) clearance K112642 for AQUILEX FLUID CONTROL SYSTEM H112, Substantially Equivalent on 2012-02-06. Applicant: W.O.M. World of Medicine AG.

Clearance details

Applicant: W.O.M. World of Medicine AG
Product code: Code HIG
Advisory panel: Obstetrics/Gynecology
Date received: 2011-09-12
Decision date: 2012-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, 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.