QTN
- 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.
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K232830 | 2023-12-08 | Vibrant, Ltd. | Vibrant System |
Official FDA classification page: QTN
Classification and pathway per current FDA publications. Data from openFDA (CC0).