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FDA 510(k)

Uterine Manipulator

K-Number: K172846 · 2018-06-26

ApplicantBeijing Hangtian Kadi Technology R&D Institute
Decision Date2018-06-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Uterine Manipulator is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Hangtian Kadi Technology R&D Institute. It received FDA 510(k) clearance on 2018-06-26 under 510(k) number K172846. 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 Manipulator?

Uterine Manipulator is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is Beijing Hangtian Kadi Technology R&D Institute. The 510(k) number is K172846.

When did Uterine Manipulator receive FDA 510(k) clearance?

Uterine Manipulator received FDA 510(k) clearance on 2018-06-26, under 510(k) number K172846.

Who is the listed applicant for Uterine Manipulator?

The FDA 510(k) record lists Beijing Hangtian Kadi Technology R&D Institute as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Uterine Manipulator?

The FDA product code for Uterine Manipulator is LKF.

Related Clinical Trials

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.

NCT05687084Uterine Manipulator Versus no Uterine Manipulator in Endometrial Cancer TrialRECRUITING

Other records listing Beijing Hangtian Kadi Technology R&D Institute 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.

K172789Specimen Retrieval Bag

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

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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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