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

Name: FDA 510(k) clearance K220202
Creator: U.S. Food and Drug Administration
Published: 2022-03-31

Substantially Equivalent

The O R Company Pty, Ltd.

FDA 510(k) clearance K220202 for Uterine ElevatOR PRO with OccludOR Balloon, Substantially Equivalent on 2022-03-31. Applicant: The O R Company Pty, Ltd.. Device class: 2.

Clearance details

Applicant: The O R Company Pty, Ltd.
Product code: Code LKF
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2022-01-24
Decision date: 2022-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrum Downs, AU

Download summary PDF View on FDA.gov ↗

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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.