K230983
- 510(k) number
- K230983
- Device name
- Unicare (K-UNICARE-USA)
- Applicant
- Tenscare, Ltd. GB
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2023-10-20
- Date received
- 2023-04-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K230983.pdf
Official FDA record: K230983
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.