510(k) DEN180060
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- April 12, 2019
- Date Received
- November 15, 2018
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
- Device Class
- Class II
- Regulation Number
- 876.5982
- Review Panel
- GU
- Submission Type
This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.