510(k) DEN210052
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 26, 2022
- Date Received
- November 30, 2021
- Clearance Type
- Direct
- 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.