Clearance Summary
KRONNER SIDE-KICK UTERINE MANIPULATOR HOLDER received FDA 510(k) clearance under submission number K130758, sponsored by Kronner Prototypes, Inc.. 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 2013-12-11.
- Submission: K130758
- Applicant / Sponsor: Kronner Prototypes, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2013-12-11
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.