Clearance Summary
MAKLER CATHETER received FDA 510(k) clearance under submission number K863785, sponsored by I M, 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 1986-12-11.
- Submission: K863785
- Applicant / Sponsor: I M, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 1986-12-11
Classification & Regulation
This clearance is catalogued under FDA product code HDR and 21 CFR 884.5250, within the Obstetrics/Gynecology review panel as a Class II device.