High Intensity Ultrasound System For Prostate Tissue Ablation
The High Intensity Ultrasound System For Prostate Tissue Ablation (product code PLP) is a Class 2 gastroenterology and urology device intended for ablation of prostate tissue, regulated under 876.4340. It requires 510(k) clearance and falls within the gastroenterology and urology medical specialty. The device is not flagged as an implant or life-sustaining product.
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Basic Information
- Product Code
- PLP
- Device Class
- FDA class 2
- Regulation Number
- 876.4340
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
Definition
Prostate tissue ablation
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 13 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251910 | Focal One® | Nov 19, 2025 | Substantially Equivalent | Edap Technomed, Inc. |
| K240296 | Tulsa Pro System (Pad-105) | May 09, 2024 | Substantially Equivalent | Profound Medical, Inc. |
| K231378 | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | Oct 30, 2023 | Substantially Equivalent | Insightec, Ltd. |
| K230692 | TULSA-PRO System | Sep 20, 2023 | Substantially Equivalent | Profound Medical, Inc. |
| K211858 | TULSA-PRO System | Sep 06, 2022 | Substantially Equivalent | Profound Medical, Inc. |
| K212150 | Exablate Prostate System | Nov 23, 2021 | Substantially Equivalent | Insightec, Inc. |
| K202286 | Tulsa-Pro System | Sep 16, 2020 | Substantially Equivalent | Profound Medical, Inc. |
| K191200 | TULSA-PRO System | Aug 15, 2019 | Substantially Equivalent | Profound Medical, Inc. |
| K172721 | FOCAL ONE | Jun 07, 2018 | Substantially Equivalent | Edap Technomed, Inc. |
| K172285 | Ablatherm Fusion | Oct 03, 2017 | Substantially Equivalent | Edap Technomed, Inc. |
| K160942 | Sonablate | Dec 21, 2016 | Substantially Equivalent | Sonacare Medical, LLC |
| K153023 | Ablatherm Integrated Imaging | Nov 06, 2015 | Substantially Equivalent | Edap Technomed, Inc. |
| DEN150011 | Sonablate 450 | Oct 09, 2015 | Unknown | Sonacare Medical, LLC |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.