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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 19, 2025 | K251910 | Focal One® Edap Technomed, Inc. | PLP |
| May 9, 2024 | K240296 | Tulsa Pro System (Pad-105) Profound Medical, Inc., CA | PLP |
| Oct 30, 2023 | K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 Insightec, Ltd., IL | PLP |
| Sep 20, 2023 | K230692 | TULSA-PRO System Profound Medical, Inc., CA | PLP |
| Sep 6, 2022 | K211858 | TULSA-PRO System Profound Medical, Inc., CA | PLP |
| Nov 23, 2021 | K212150 | Exablate Prostate System Insightec, Inc. | PLP |
| Sep 16, 2020 | K202286 | Tulsa-Pro System Profound Medical, Inc., CA | PLP |
| Aug 15, 2019 | K191200 | TULSA-PRO System Profound Medical, Inc., CA | PLP |
| Jun 7, 2018 | K172721 | FOCAL ONE Edap Technomed, Inc. | PLP |
| Oct 3, 2017 | K172285 | Ablatherm Fusion Edap Technomed, Inc. | PLP |
| Dec 21, 2016 | K160942 | Sonablate Sonacare Medical, LLC | PLP |
| Nov 6, 2015 | K153023 | Ablatherm Integrated Imaging Edap Technomed, Inc. | PLP |
| Oct 9, 2015 | DEN150011 | Sonablate 450 Sonacare Medical, LLC | PLP |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.