HYSTEREOSCOPY PUMP HM4— 510(k) K022449

Substantially Equivalent

W.O.M. World of Medicine AG

FDA 510(k) clearance K022449 for HYSTEREOSCOPY PUMP HM4, Substantially Equivalent on 2003-04-10. 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: 2002-07-26
Decision date: 2003-04-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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.