QTN · Orally Ingested Transient Device For Constipation
Gastroenterology, Urology · 21 CFR 876.5940 · Class 2
Overview
| Product Code | QTN |
|---|---|
| Device Name | Orally Ingested Transient Device For Constipation |
| Regulation | 21 CFR 876.5940 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
Identification
An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation. The Vibrant System is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least one month.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, with risks mitigated by general controls and the identified special controls.
Special Controls
In combination with the general controls of the FD&C Act, an orally ingested transient device for constipation is subject to the following special controls:
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232830 | Vibrant System | Vibrant, Ltd. | Dec 8, 2023 | SESE |
| K223031 | Vibrant System | Vibrant, Ltd. | Jan 13, 2023 | SESE |
| DEN210052 | Vibrant System | Vibrant, Ltd. | Aug 26, 2022 | DENG |
Top Applicants
- Vibrant, Ltd. — 3 clearances
