510(k) DEN150011
DEN150011 is an FDA 510(k) premarket notification submitted by Sonacare Medical, LLC for the device "Sonablate 450". The FDA issued a decision of De Novo Granted on October 9, 2015. 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. Sonacare Medical, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 9, 2015
- Date Received
- March 23, 2015
- Clearance Type
- Direct
- 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