K230692
- 510(k) number
- K230692
- Device name
- TULSA-PRO System
- Applicant
- Profound Medical, Inc. CA
- Product code
- PLP — High Intensity Ultrasound System For Prostate Tissue
- Decision date
- 2023-09-20
- Date received
- 2023-03-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K230692.pdf
Official FDA record: K230692
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.