Clearance Summary
CONCEIVEX LATEX-FREE SEMEN COLLECTOR received FDA 510(k) clearance under submission number K080752, sponsored by Conceivex, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2008-05-14.
- Submission: K080752
- Applicant / Sponsor: Conceivex, Inc.
- Clearance pathway: Special
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5250
- Decision date: 2008-05-14
Classification & Regulation
This clearance is catalogued under FDA product code OBB and 21 CFR 884.5250, within the Obstetrics/Gynecology review panel as a Class II device.