Clearance Summary
Synthetic Polyisoprene Lubricated Male Condom - 5 senses received FDA 510(k) clearance under submission number K182438, sponsored by Sxwell USA, LLC. 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 2018-12-06.
- Submission: K182438
- Applicant / Sponsor: Sxwell USA, LLC
- Clearance pathway: Abbreviated
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2018-12-06
Classification & Regulation
This clearance is catalogued under FDA product code MOL and 21 CFR 884.5300, within the Obstetrics/Gynecology review panel as a Class II device.