Clearance Summary
ROWDEN UTERINE MANIPULATOR INJECTOR AND RUMI received FDA 510(k) clearance under submission number K932115, sponsored by Blairden Precision Instruments, 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 1994-06-24.
- Submission: K932115
- Applicant / Sponsor: Blairden Precision Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-06-24
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.