510(k) K230692
K230692 is an FDA 510(k) premarket notification submitted by Profound Medical, Inc. for the device "TULSA-PRO System". The FDA issued a decision of Substantially Equivalent on September 20, 2023. The device falls under product code PLP (High Intensity Ultrasound System For Prostate Tissue Ablation), a Class II device regulated under 21 CFR 876.4340. Profound Medical, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 20, 2023
- Date Received
- March 13, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Intensity Ultrasound System For Prostate Tissue Ablation
- Device Class
- Class II
- Regulation Number
- 876.4340
- Review Panel
- GU
- Submission Type
Prostate tissue ablation