| Device |
ingested, transient, space occupying device for weight management and/or weight loss |
| Regulation Description |
Ingested, transient, space occupying device for weight management and/or weight loss. |
| Definition |
This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract. |
| Physical State |
This device is supplied as a hydrogel filled capsule that is ingested orally. |
| Technical Method |
This device occupies space in the stomach to promotes fullness to help patients manage and/or lose weight. The device passes from the body via the natural gastrointestinal tract. |
| Target Area |
The device is ingested orally, transiently occupies space in the stomach, and passes from the body via the natural gastrointestinal tract. |
| Regulation Medical Specialty |
Gastroenterology/Urology |
| Review Panel |
Gastroenterology/Urology |
|---|
| Product Code | QFQ |
|---|
| Premarket Review |
Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices
(OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
876.5982
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
