Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is The O R Company Pty, Ltd.. It received FDA 510(k) clearance on 2022-03-31 under 510(k) 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. The listed applicant is The O R Company Pty, Ltd.. The 510(k) number is K220202.

When did Uterine ElevatOR PRO with OccludOR Balloon receive FDA 510(k) clearance?

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

Who is the listed applicant for Uterine ElevatOR PRO with OccludOR Balloon?

The FDA 510(k) record lists The O R Company Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing The O R Company Pty, Ltd. as applicant

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.

K212505DUMI ManipulatOR

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.K222798Rejoni Intrauterine CatheterRejoni, Inc.

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.

↑