510(k) K153513— Insufflator 50L FM134

Substantially Equivalent

W.O.M. World of Medicine GmbH

Clearance details

Applicant: W.O.M. World of Medicine GmbH
Product code: Code HIF
Advisory panel: Obstetrics/Gynecology
Date received: 2015-12-07
Decision date: 2016-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Berlin, DE

Adverse events under product code HIF

product code HIF

Death: 19
Injury: 578
Malfunction: 5,639
Total: 6,236

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.