DEN180060 is an FDA 510(k) submission 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 Not Cleared (DENG) decision on April 12, 2019.
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 | DEN180060 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | November 15, 2018 |
| Decision Date | April 12, 2019 |
| Days to Decision | 148 days |
| Submission Type | Direct |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | - |
| 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. |