Clearance Summary
BioGenesis Fertility Lubricant received FDA 510(k) clearance under submission number K190872, sponsored by Good Clean Love, 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 2019-11-07.
- Submission: K190872
- Applicant / Sponsor: Good Clean Love, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2019-11-07
Classification & Regulation
This clearance is catalogued under FDA product code PEB and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.