Clearance Summary
Okamoto 002 Lubricated Polyurethane Male Condom received FDA 510(k) clearance under submission number K203541, sponsored by Okamoto USA, 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 2022-02-25.
- Submission: K203541
- Applicant / Sponsor: Okamoto USA, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.5300
- Decision date: 2022-02-25
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.