Product code QTN

Device name

Orally Ingested Transient Device For Constipation

Medical specialty

Gastroenterology, Urology

Device class

2

Regulation number

876.5940

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.

Source

FDA openFDA device classification dataset