510(k) K172285
K172285 is an FDA 510(k) premarket notification submitted by Edap Technomed, Inc. for the device "Ablatherm Fusion". The FDA issued a decision of Substantially Equivalent on October 3, 2017. 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. Edap Technomed, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2017
- Date Received
- July 28, 2017
- 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