Clearance Summary
MX4043---SERIES, INTRAUTERINE PRESSURE CATHETER received FDA 510(k) clearance under submission number K910227, sponsored by Medex, 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 1991-04-03.
- Submission: K910227
- Applicant / Sponsor: Medex, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.2700
- Decision date: 1991-04-03
Classification & Regulation
This clearance is catalogued under FDA product code KXO and 21 CFR 884.2700, within the Obstetrics/Gynecology review panel as a Class II device.