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QTNClass II

Orally Ingested Transient Device For Constipation

21 CFR 876.5940 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QTN is the FDA product code for Orally Ingested Transient Device For Constipation, a class II device type, regulated under 21 CFR 876.5940. FDA's definition for this code reads: "An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QTN
Device name
Orally Ingested Transient Device For Constipation
FDA 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.
Regulation
21 CFR 876.5940
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code QTN

By decision year
3 clearances under product code QTN with a decision year between 2022 and 2023, 2023 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code QTN by decision year
YearClearances
20221
20232

Applicants with the most clearances

Product code QTN
Applicants holding the most 510(k) clearances under product code QTN
ApplicantClearances
Vibrant Ltd3

Companies listing this code with FDA

Companies whose registered establishments list this code