Data / Medical devices / Israel / Epitomee Medical Ltd.
Epitomee Medical Ltd.: FDA-registered device maker in Caesarea Central, Israel, 1 510(k) clearance
Epitomee Medical Ltd. is registered with the FDA (registration 3033524253) in Caesarea Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 13, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033524253
- Address
- 17 Hatochen street, Caesarea Central, Israel, 3079892
- Owner or operator
- Epitomee Medical Ltd. (10091964)
- Roles
- Manufacturer
- First device listed
- November 20, 2024
- Registered through
- 2027
- Brand names listed
- Epitomee
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss | QFQ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 13, 2024 | K240544 | Epitomee | QFQ | Substantially Equivalent | Epitomee Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated September 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.