Clearance Summary
Astroglide X Silicone Personal Lubricant received FDA 510(k) clearance under submission number K210242, sponsored by Biofilm, 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 2021-04-28.
- Submission: K210242
- Applicant / Sponsor: Biofilm, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2021-04-28
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.