QTN — Orally Ingested Transient Device For Constipation Class II

FDA Device Classification

Classification Details

Product Code
QTN
Device Class
Class II
Regulation Number
876.5940
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K232830vibrantVibrant SystemDecember 8, 2023
K223031vibrantVibrant SystemJanuary 13, 2023
DEN210052vibrantVibrant SystemAugust 26, 2022