Product code NUB

Device name

Colonic Irrigation System, General Well Being

Medical specialty

Gastroenterology, Urology

Device class

3

Regulation number

876.5220

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Eligible

Definition

Call for PMAs on 12/26/96 per 61 FR 50707 on 9/27/96 - Colon cleansing for routine general well being

Source

FDA openFDA device classification dataset