Uterine Manipulator
K-Number: K172846 · 2018-06-26
Decision Date2018-06-26
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent
Device Summary
Uterine Manipulator is a medical device manufactured by Beijing Hangtian Kadi Technology R&D Institute. It received FDA 510(k) clearance on 2018-06-26 under approval 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. It is manufactured by Beijing Hangtian Kadi Technology R&D Institute. The 510(k) number is K172846.
When was Uterine Manipulator approved by the FDA?
Uterine Manipulator received FDA 510(k) clearance on 2018-06-26, under approval number K172846.
What company makes Uterine Manipulator?
Uterine Manipulator is manufactured by Beijing Hangtian Kadi Technology R&D Institute.
What is the FDA product code for Uterine Manipulator?
The FDA product code for Uterine Manipulator is LKF.
Related Clinical Trials
Other Devices by Beijing Hangtian Kadi Technology R&D Institute
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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.