FDA product code PLP: High Intensity Ultrasound System For Prostate Tissue Ablation
PLP is the FDA product code for high intensity ultrasound system for prostate tissue ablation. It is a Class II device, regulated under 21 CFR 876.4340 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 12 510(k) submissions under PLP, 5 in the last five years, from 5 different applicants. The average 510(k) review took 163 days (median 144); 125 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 1 recall for PLP devices.
Definition
Prostate tissue ablation
Classification
| Field | Value |
|---|---|
| Device name | High Intensity Ultrasound System For Prostate Tissue Ablation |
| Device class | Class II |
| Regulation | 21 CFR 876.4340 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for PLP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 67 |
| 2018 | 1 | 272 |
| 2019 | 1 | 101 |
| 2020 | 1 | 35 |
| 2021 | 1 | 137 |
| 2022 | 1 | 447 |
| 2023 | 2 | 181 |
| 2024 | 1 | 98 |
| 2025 | 1 | 152 |
Compare with all 510(k) review times · Search every PLP clearance
Top PLP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Profound Medical, Inc. | 5 | 2024-05-09 |
| Edap Technomed, Inc. | 4 | 2025-11-19 |
| Insightec, Ltd. | 1 | 2023-10-30 |
| Insightec, Inc. | 1 | 2021-11-23 |
| Sonacare Medical, LLC | 1 | 2016-12-21 |
Most recent PLP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251910 | Edap Technomed, Inc. | Focal One® | 2025-11-19 | 152 |
| K240296 | Profound Medical, Inc. | Tulsa Pro System (Pad-105) | 2024-05-09 | 98 |
| K231378 | Insightec, Ltd. | Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 | 2023-10-30 | 171 |
| K230692 | Profound Medical, Inc. | TULSA-PRO System | 2023-09-20 | 191 |
| K211858 | Profound Medical, Inc. | TULSA-PRO System | 2022-09-06 | 447 |
Recalls for PLP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2017-08-14.
| Year | Recalls |
|---|---|
| 2017 | 1 |
Frequently asked questions
What is FDA product code PLP?
PLP is the FDA product code for high intensity ultrasound system for prostate tissue ablation. It is a Class II device, regulated under 21 CFR 876.4340 and reviewed by the Gastroenterology and Urology panel.
What device class is PLP?
Class II, regulation 21 CFR 876.4340. Typical premarket route: 510(k).
How long does a 510(k) take for product code PLP?
Across 12 cleared submissions the average was 163 days from receipt to decision (median 144).
Which companies have the most PLP clearances?
Profound Medical, Inc. (5); Edap Technomed, Inc. (4); Insightec, Ltd. (1); Insightec, Inc. (1); Sonacare Medical, LLC (1).
Have PLP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2017-08-14.
Next steps
- Run an FDA pathway report with predicate devices for product code PLP
- Run a recall and safety report across every PLP manufacturer
- Watch product code PLP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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