Clearance Summary
KOLPEXIN SPHERE received FDA 510(k) clearance under submission number K032644, sponsored by Adamed , Ltd.. 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 2004-05-28.
- Submission: K032644
- Applicant / Sponsor: Adamed , Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.3575
- Decision date: 2004-05-28
Classification & Regulation
This clearance is catalogued under FDA product code HHW and 21 CFR 884.3575, within the Obstetrics/Gynecology review panel as a Class II device.