FDA 510(k)

Rejoni Intrauterine Catheter

Número K: K222798 · 2022-12-16

Data da decisão2022-12-16

Código do produtoLKF

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

Rejoni Intrauterine Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Rejoni, Inc.. It received FDA 510(k) clearance on 2022-12-16 under 510(k) number K222798. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Rejoni Intrauterine Catheter?

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

When did Rejoni Intrauterine Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Rejoni Intrauterine Catheter?

The FDA 510(k) record lists Rejoni, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rejoni Intrauterine Catheter?

The FDA product code for Rejoni Intrauterine Catheter is LKF.

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