Product code QON

Device name

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

Medical specialty

Gastroenterology, Urology

Device class

3

Regulation number

876.5270

Review panel

GU

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Treatment of chronic fecal incontinence

Source

FDA openFDA device classification dataset