K243079
- 510(k) number
- K243079
- Device name
- NeuroTrac® MyoPlus Pro (MYO120U)
- Applicant
- Verity Medical , Ltd. IE
- Product code
- KPI — Stimulator, Electrical, Non-Implantable, For Inconti
- Decision date
- 2025-06-26
- Date received
- 2024-09-30
- 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: K243079.pdf
Official FDA record: K243079
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.