Clearance Summary
PIONEER PRO-PUMP received FDA 510(k) clearance under submission number K914220, sponsored by Pioneer Medical, 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 1992-03-04.
- Submission: K914220
- Applicant / Sponsor: Pioneer Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1175
- Decision date: 1992-03-04
Classification & Regulation
This clearance is catalogued under FDA product code HHK and 21 CFR 884.1175, within the Obstetrics/Gynecology review panel as a Class II device.