De Novo DEN150011

Device: Sonablate 450
Contact: dawn byrd burleson
De Novo number: DEN150011
Product code: PLP
Regulation: 876.4340
Classification name: high intensity ultrasound system for prostate tissue ablation
Decision: granted (DENG)
Decision date: 2015-10-09
Date received: 2015-03-23
Classification advisory: Gastroenterology/Urology
Review advisory: Gastroenterology/Urology
Type: Direct

Current FDA Classification#

Product code: PLP
Device name: High Intensity Ultrasound System For Prostate Tissue Ablation
Medical specialty: Gastroenterology, Urology
Device class: 2
Regulation: 876.4340
Implant: N
Life sustain/support: N