Clearance Summary
INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant received FDA 510(k) clearance under submission number K242645, sponsored by Project Chemistry, 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 2024-12-06.
- Submission: K242645
- Applicant / Sponsor: Project Chemistry, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2024-12-06
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.