Clearance Summary
Carex Hybrid Personal Lubricant received FDA 510(k) clearance under submission number K223519, sponsored by Karex Industries Sdn. Bhd.. 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 2023-08-11.
- Submission: K223519
- Applicant / Sponsor: Karex Industries Sdn. Bhd.
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2023-08-11
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.