K230133 is an FDA 510(k) clearance for the Plenity. This device is classified as a Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss (Class II - Special Controls, product code QFQ).
Submitted by Gelesis, Inc. (Boston, US). The FDA issued a Cleared decision on January 19, 2024, 367 days after receiving the submission on January 17, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 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..
| 510(k) Number | K230133 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 17, 2023 |
| Decision Date | January 19, 2024 |
| Days to Decision | 367 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | QFQ - Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5982 |
| 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. |