K240544 is an FDA 510(k) clearance for the Epitomee. Classified as Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss (product code QFQ), Class II - Special Controls.
Submitted by Epitomee Medical , Ltd. (Caesarea, IL). The FDA issued a Cleared decision on September 13, 2024 after a review of 199 days - an extended review cycle.
This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5982 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.
View all Epitomee Medical , Ltd. devices
NCT03610958
Completed
Interventional
Industry-sponsored
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.
Prospective, Single Center, Open-labeled Single Arm Study, to Asses the Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss in Healthy Over Weight and Obese Subjects
| Condition studied |
Overweight; Obesity |
| Study design |
Single group |
| Eligibility |
All sexes
· 21 Years+
· Healthy volunteers accepted
|
| Principal investigator |
Haim Shirin, MD |
| Sponsor |
Epitomee medical
(industry)
|
Started 2014-09-04
→
Primary completion 2018-09-04
Primary outcome
Safety evaluation of the Device administration.
Study completed - no results published.
This trial concluded in 2018 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov