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510(k) K240544

Epitomee by Epitomee Medical , Ltd. — Product Code QFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2024
Date Received
February 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Device Class
Class II
Regulation Number
876.5982
Review Panel
GU
Submission Type

This device is an ingested material that transiently occupies space in the stomach. The device passes from the body via the natural gastrointestinal tract.

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