QFQClass II
Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss
Gastroenterology, Urology · 21 CFR 876.5982
This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.
MDR events43All time
Recalls0All time
Registered firms5Currently listed
510(k) clearances3All time
Recent MDR events
43 adverse event reports on file
- PLENITYJun 29, 2023InjuryGelesis Srl3012121187-2023-00011
- PLENITYJun 23, 2023InjuryGelesis Srl3012121187-2023-00010
- PLENITYApr 21, 2023InjuryGelesis Srl3012121187-2023-00008
- PLENITYApr 5, 2023InjuryRo / Gelesis Inc.MW5116393
- PLENITYMar 9, 2023InjuryGelesis Srl3012121187-2023-00004
- PLENITYFeb 14, 2023InjuryGelesis Srl3012121187-2023-00002
- PLENITYJan 12, 2023InjuryGelesis Srl3012121187-2023-00001
- PLENITYNov 25, 2022InjuryGelesis Srl3012121187-2022-01102
- PLENITYNov 7, 2022InjuryGelesis Srl3012121187-2022-01089
- PLENITYOct 11, 2022InjuryGelesis Srl3012121187-2022-01027
Event type breakdown
Injury43
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
5 firms currently registered for this product code
510(k) clearances
3 clearances for this product code