QTN

Orally Ingested Transient Device For Constipation

Product code
QTN
Device name
Orally Ingested Transient Device For Constipation
Device class
Class 2
21 CFR
21 CFR 876.5940
Medical specialty
Gastroenterology, Urology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-12-08.

NumberDecision dateApplicantDevice nameSummary
K2328302023-12-08Vibrant, Ltd.Vibrant SystemPDF

1 summaries are archived here for direct download.

Official FDA classification page: QTN
Classification and pathway per current FDA publications. Data from openFDA (CC0).