Product code QTN
- Device name
- Orally Ingested Transient Device For Constipation
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5940
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| K232830 | Vibrant System | Vibrant, Ltd. | 2023-12-08 |
| K223031 | Vibrant System | Vibrant, Ltd. | 2023-01-13 |
| DEN210052 | Vibrant System | Vibrant, Ltd. | 2022-08-26 |