FDA 510(k)

Rejoni Intrauterine Catheter

K-Number: K222798 · 2022-12-16

Decision Date2022-12-16

Product CodeLKF

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

Rejoni Intrauterine Catheter is a medical device manufactured by Rejoni, Inc.. It received FDA 510(k) clearance on 2022-12-16 under approval number K222798. 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 Rejoni Intrauterine Catheter?

Rejoni Intrauterine Catheter is a medical device that received FDA 510(k) clearance on 2022-12-16. It is manufactured by Rejoni, Inc.. The 510(k) number is K222798.

When was Rejoni Intrauterine Catheter approved by the FDA?

Rejoni Intrauterine Catheter received FDA 510(k) clearance on 2022-12-16, under approval number K222798.

What company makes Rejoni Intrauterine Catheter?

Rejoni Intrauterine Catheter is manufactured by Rejoni, Inc..

What is the FDA product code for Rejoni Intrauterine Catheter?

The FDA product code for Rejoni Intrauterine Catheter is LKF.

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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.