FDA 510(k)

DUMI ManipulatOR

K-Number: K212505 · 2022-01-10

Decision Date2022-01-10

Product CodeLKF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

DUMI ManipulatOR is a medical device manufactured by The O R Company Pty, Ltd.. It received FDA 510(k) clearance on 2022-01-10 under approval number K212505. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUMI ManipulatOR?

DUMI ManipulatOR is a medical device that received FDA 510(k) clearance on 2022-01-10. It is manufactured by The O R Company Pty, Ltd.. The 510(k) number is K212505.

When was DUMI ManipulatOR approved by the FDA?

DUMI ManipulatOR received FDA 510(k) clearance on 2022-01-10, under approval number K212505.

What company makes DUMI ManipulatOR?

DUMI ManipulatOR is manufactured by The O R Company Pty, Ltd..

What is the FDA product code for DUMI ManipulatOR?

The FDA product code for DUMI ManipulatOR is LKF.

Other Devices by The O R Company Pty, Ltd.

K220202Uterine ElevatOR PRO with OccludOR Balloon

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.