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FDA 510(k)

Rejoni Intrauterine Catheter

K-Number: K222798 · 2022-12-16

ApplicantRejoni, Inc.
Decision Date2022-12-16
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Related Clinical Trials

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NCT06634719Juveena Hydrogel System Feasibility Study for Heavy Menstrual Bleeding (HMB)COMPLETED

Related Devices (Code: LKF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K223064ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc.

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.

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