Clearance Summary
in2 Smart (in2S) received FDA 510(k) clearance under submission number K252809, sponsored by Virility Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2026-04-06.
- Submission: K252809
- Applicant / Sponsor: Virility Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.5026
- Decision date: 2026-04-06
Classification & Regulation
This clearance is catalogued under FDA product code QRC and 21 CFR 876.5026, within the Gastroenterology, Urology review panel as a Class II device.