DEN210052 is an FDA 510(k) submission for the Vibrant System. This device is classified as a Orally Ingested Transient Device For Constipation (Class II - Special Controls, product code QTN).
Submitted by Vibrant, Ltd. (Yokneam, IL). The FDA issued a Not Cleared (DENG) decision on August 26, 2022.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5940. 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) Number | DEN210052 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 30, 2021 |
| Decision Date | August 26, 2022 |
| Days to Decision | 269 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| Product Code | QTN - Orally Ingested Transient Device For Constipation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5940 |
| 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. |