510(k) K160942
K160942 is an FDA 510(k) premarket notification submitted by Sonacare Medical, LLC for the device "Sonablate". The FDA issued a decision of Substantially Equivalent on December 21, 2016. 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
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 2016
- Date Received
- April 5, 2016
- 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