Product code OEJ

Device name

Transurethral Electrosurgical Unit, Benign Prostatic Hyperplasia

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.4300

Review panel

SU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Ablation of prostatic tissue for the treatment of benign prostatic hyperplasia

Source

FDA openFDA device classification dataset