Clearance Summary
Visby Medical Men's Sexual Health Test received FDA 510(k) clearance under submission number K251501, sponsored by Visby Medical, Inc.. The device was reviewed via the Dual Track premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2025-10-01.
- Submission: K251501
- Applicant / Sponsor: Visby Medical, Inc.
- Clearance pathway: Dual Track
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3393
- Decision date: 2025-10-01
Classification & Regulation
This clearance is catalogued under FDA product code QEP and 21 CFR 866.3393, within the Microbiology review panel as a Class II device.