K240544 is an FDA 510(k) clearance for the Epitomee. 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 Epitomee Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on September 13, 2024, 199 days after receiving the submission on February 27, 2024.
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 | K240544 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2024 |
| Decision Date | September 13, 2024 |
| Days to Decision | 199 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. |