K240296
- 510(k) number
- K240296
- Device name
- Tulsa Pro System (Pad-105)
- Applicant
- Profound Medical, Inc. CA
- Product code
- PLP — High Intensity Ultrasound System For Prostate Tissue
- Decision date
- 2024-05-09
- Date received
- 2024-02-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240296
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.