Definition: Prostate Tissue Ablation
| Device Type ID | 2107 |
| Device Name | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Physical State | The System Consists Of A Console, A Probe With Therapy Transducer(s), And Single Use Accessories. |
| Technical Method | Uses High Intensity Ultrasound To Heat Target Tissue Within The Prostate Gland, Causing Coagulation Necrosis Of That Tissue. |
| Target Area | The Prostate Gland |
| Regulation Description | High Intensity Ultrasound System For Prostate Tissue Ablation. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Urology And Lithotripsy Devices Branch (ULDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.4340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2107 |
| Device | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Product Code | PLP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | High Intensity Ultrasound System For Prostate Tissue Ablation. |
| CFR Regulation Number | 876.4340 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EDAP TECHNOMED | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
EDAP TMS, FRANCE SA | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
SONACARE MEDICAL, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SONACARE MEDICAL, LLC. | ||
GRANTED | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Edap Technomed Inc. | II | Oct-26-2017 |