FDA Product Code PLP: High Intensity Ultrasound System For Prostate Tissue Ablation
Prostate Tissue Ablation
Leading manufacturers include Profound Medical, Inc., InSightec, Inc. and Insightec , Ltd..
FDA 510(k) Cleared High Intensity Ultrasound System For Prostate Tissue Ablation Devices (Product Code PLP)
About Product Code PLP - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code PLP since 2015, with 12 receiving FDA clearance (average review time: 166 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
FDA review times for PLP submissions have been consistent, averaging 152 days recently vs 167 days historically.
PLP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →