IUR FLUID MANAGEMENT SYSTEM— 510(k) K031616

Substantially Equivalent

W.O.M. World of Medicine AG

FDA 510(k) clearance K031616 for IUR FLUID MANAGEMENT SYSTEM, Substantially Equivalent on 2003-08-13. 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: 2003-05-23
Decision date: 2003-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Alexandria, VA, 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.