Panels › Gastroenterology, Urology › Product code PLP · Class 2
High Intensity Ultrasound System For Prostate Tissue Ablation
Regulation 876.4340
1510(k)s in 12 months (13 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PLP
| Company | 510(k)s | Recalls |
|---|---|---|
| Edap Technomed, Inc. | 4 | 1 |
| Profound Medical, Inc. | 5 | 0 |
| Insightec, Inc. | 2 | 0 |
| Sonacare Medical, LLC | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2017 | Edap Technomed Inc. Ablatherm(R) Integrated Imaging, High Intensity Ultrasound System For Prostate Tissue Ablation
Transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue Terminated |
PLP | K153023 |
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