QTN
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Orally Ingested Transient Device For Constipation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5940
- Medical specialty
- Gastroenterology, Urology
- 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.
- Adverse events (MAUDE)
- 2026: 25
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Vibrant System (K232830) | Vibrant, Ltd. | 2023-12-08 |
| Vibrant System (K223031) | Vibrant, Ltd. | 2023-01-13 |
| Vibrant System (DEN210052) | Vibrant, Ltd. | 2022-08-26 |
Track QTN automatically
Every clearance here is in the API, with alerts when new ones post.