DeviceClearance

Product code QTN— Gastroenterology, Urology

Vibrant System

Classification name
Orally Ingested Transient Device For Constipation
Device class
Class 2
Regulation
21 CFR 876.5940
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code QTN under 21 CFR 876.5940, via openFDA

Market context for product code QTN

FDA has cleared 3 devices under product code QTN between 2022 and 2023, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QTN

Recent clearances under product code QTN

Data sourced from openFDA. This site is unofficial and independent of the FDA.