Clearance Summary
O-RING Condom received FDA 510(k) clearance under submission number K150828, sponsored by O-Ring Products, LLC. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2015-12-18.
- Submission: K150828
- Applicant / Sponsor: O-Ring Products, LLC
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2015-12-18
Classification & Regulation
This clearance is catalogued under FDA product code HIS and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.