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FDA 510(k)

Uterine ElevatOR PRO with OccludOR Balloon

K-Number: K220202 · 2022-03-31

ApplicantThe O R Company Pty, Ltd.
Decision Date2022-03-31
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Uterine ElevatOR PRO with OccludOR Balloon is a medical device manufactured by The O R Company Pty, Ltd.. It received FDA 510(k) clearance on 2022-03-31 under approval number K220202. 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 Uterine ElevatOR PRO with OccludOR Balloon?

Uterine ElevatOR PRO with OccludOR Balloon is a medical device that received FDA 510(k) clearance on 2022-03-31. It is manufactured by The O R Company Pty, Ltd.. The 510(k) number is K220202.

When was Uterine ElevatOR PRO with OccludOR Balloon approved by the FDA?

Uterine ElevatOR PRO with OccludOR Balloon received FDA 510(k) clearance on 2022-03-31, under approval number K220202.

What company makes Uterine ElevatOR PRO with OccludOR Balloon?

Uterine ElevatOR PRO with OccludOR Balloon is manufactured by The O R Company Pty, Ltd..

What is the FDA product code for Uterine ElevatOR PRO with OccludOR Balloon?

The FDA product code for Uterine ElevatOR PRO with OccludOR Balloon is LKF.

Related Clinical Trials

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Official Source

View on FDA Database →

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

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