K232830 is an FDA 510(k) clearance 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 Cleared decision on December 8, 2023, 86 days after receiving the submission on September 13, 2023.
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 | K232830 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 13, 2023 |
| Decision Date | December 08, 2023 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |