DUMI ManipulatOR— 510(k) K212505

Substantially Equivalent

The O R Company Pty, Ltd.

FDA 510(k) clearance K212505 for DUMI ManipulatOR, Substantially Equivalent on 2022-01-10. Applicant: 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: 2021-08-09
Decision date: 2022-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carrum Downs, AU

Download summary PDF View on FDA.gov ↗

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.