510(k) K223031
K223031 is an FDA 510(k) premarket notification submitted by Vibrant, Ltd. for the device "Vibrant System". The FDA issued a decision of Substantially Equivalent on January 13, 2023. The device falls under product code QTN (Orally Ingested Transient Device For Constipation), a Class II device regulated under 21 CFR 876.5940. Vibrant, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2023
- Date Received
- September 29, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orally Ingested Transient Device For Constipation
- Device Class
- Class II
- Regulation Number
- 876.5940
- Review Panel
- GU
- Submission Type
An orally ingested transient device for constipation is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation.