510(k) K230133
K230133 is an FDA 510(k) premarket notification submitted by Gelesis, Inc. for the device "Plenity". The FDA issued a decision of Substantially Equivalent on January 19, 2024. The device falls under product code QFQ (Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss), a Class II device regulated under 21 CFR 876.5982. Gelesis, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2024
- Date Received
- January 17, 2023
- Clearance Type
- Traditional
- 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.