Product code NOY

Device name

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5550

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

The device comprises one or more objects placed in a blood vessel to permanently obstruct blood flow to the prostate to treat benign prostatic hyperplasia (BPH).

Source

FDA openFDA device classification dataset