K234061
- 510(k) number
- K234061
- Device name
- StarFormer
- Applicant
- Fotona D.O.O. SI
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2024-07-01
- Date received
- 2023-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K234061.pdf
Official FDA record: K234061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.