Clearance Summary
APPLE MEDICAL ONE-TOUCH UTERINE SAMPLER received FDA 510(k) clearance under submission number K000026, sponsored by Apple Medical Corp.. 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 2000-03-31.
- Submission: K000026
- Applicant / Sponsor: Apple Medical Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1175
- Decision date: 2000-03-31
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.