PLP — High Intensity Ultrasound System For Prostate Tissue Ablation Class II
FDA product code PLP covers "High Intensity Ultrasound System For Prostate Tissue Ablation", a Class II medical device regulated under 21 CFR 876.4340. Submissions are reviewed by the Gastroenterology, Urology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PLP
- Device Class
- Class II
- Regulation Number
- 876.4340
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Definition
Prostate tissue ablation
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251910 | edap technomed | Focal One® | November 19, 2025 |
| K240296 | profound medical | Tulsa Pro System (Pad-105) | May 9, 2024 |
| K231378 | insightec | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V | October 30, 2023 |
| K230692 | profound medical | TULSA-PRO System | September 20, 2023 |
| K211858 | profound medical | TULSA-PRO System | September 6, 2022 |
| K212150 | insightec | Exablate Prostate System | November 23, 2021 |
| K202286 | profound medical | Tulsa-Pro System | September 16, 2020 |
| K191200 | profound medical | TULSA-PRO System | August 15, 2019 |
| K172721 | edap technomed | FOCAL ONE | June 7, 2018 |
| K172285 | edap technomed | Ablatherm Fusion | October 3, 2017 |
| K160942 | sonacare medical | Sonablate | December 21, 2016 |
| K153023 | edap technomed | Ablatherm Integrated Imaging | November 6, 2015 |
| DEN150011 | sonacare medical | Sonablate 450 | October 9, 2015 |