The following data is part of a De Novo classification by Gelesis, Inc. with the FDA for Plenity.
| DeNovo ID | DEN180060 |
| Device Name: | Plenity |
| Classification | Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss |
| Applicant | Gelesis, Inc. 501 Boylston Street, Suite 6102 Boston, MA 02116 |
| Contact | Eyal Ron |
| Product Code | QFQ |
| CFR Regulation Number | 876.5982 [🔎] |
| Decision | Granted (DENG) |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2018-11-15 |
| Decision Date | 2019-04-12 |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860517002627 | DEN180060 | 000 |
| 00860517002634 | DEN180060 | 000 |