Clearance Summary
Ah!Yes Ob Coco Personal Lubricant received FDA 510(k) clearance under submission number K191411, sponsored by Bio-Tech Lubricants, 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 2020-02-06.
- Submission: K191411
- Applicant / Sponsor: Bio-Tech Lubricants, Ltd.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2020-02-06
Classification & Regulation
This clearance is catalogued under FDA product code NUC and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.