K223031 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 January 13, 2023, 106 days after receiving the submission on September 29, 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 | K223031 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2022 |
| Decision Date | January 13, 2023 |
| Days to Decision | 106 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. |