Product code PLP

Device name

High Intensity Ultrasound System For Prostate Tissue Ablation

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.4340

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Prostate tissue ablation

Source

FDA openFDA device classification dataset