K252809
- 510(k) number
- K252809
- Device name
- in2 Smart (in2S)
- Applicant
- Virility Medical , Ltd. IL
- Product code
- QRC — Non-Implanted Electrical Stimulation Device For Mana
- Decision date
- 2026-04-06
- Date received
- 2025-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K252809.pdf
Official FDA record: K252809
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.