PLP

High Intensity Ultrasound System For Prostate Tissue Ablation

Product code

PLP

Device name

High Intensity Ultrasound System For Prostate Tissue Ablation

Device class

Class 2

21 CFR

21 CFR 876.4340

Medical specialty

Gastroenterology, Urology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

4

Summaries archived here

3 (direct download)

510(k) clearances (all years, FDA)

13 (all years; only the last 3 years are listed here)

FDA classification definition

Prostate tissue ablation

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2025-11-19.

3 summaries are archived here for direct download.