510(k) K220202— Uterine ElevatOR PRO with OccludOR Balloon

Substantially Equivalent

The O R Company Pty, Ltd.

Clearance details

Applicant: The O R Company Pty, Ltd.
Product code: Code LKF
Advisory panel: Obstetrics/Gynecology
Date received: 2022-01-24
Decision date: 2022-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrum Downs, AU

Adverse events under product code LKF

product code LKF

Malfunction: 643
Other: 2
Total: 645

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.