Clearance Summary
UTERINE MANIPULATOR INJECTOR CANNULA, MODEL R57-450 received FDA 510(k) clearance under submission number K010296, sponsored by Marina Medical 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 2001-04-11.
- Submission: K010296
- Applicant / Sponsor: Marina Medical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2001-04-11
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.