Clearance Summary
Uterine Manipulator received FDA 510(k) clearance under submission number K172846, sponsored by Beijing Hangtian Kadi Technology R&D Institute. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2018-06-26.
- Submission: K172846
- Applicant / Sponsor: Beijing Hangtian Kadi Technology R&D Institute
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2018-06-26
Classification & Regulation
This clearance is catalogued under FDA product code LKF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.