Clearance Summary
COLPO-MASTER received FDA 510(k) clearance under submission number K073053, sponsored by United Products & 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 2007-11-15.
- Submission: K073053
- Applicant / Sponsor: United Products & Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1630
- Decision date: 2007-11-15
Classification & Regulation
This clearance is catalogued under FDA product code HEX and 21 CFR 884.1630, within the Obstetrics/Gynecology review panel as a Class II device.