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510(k) K240544

Device
Epitomee
Applicant
Epitomee Medical , Ltd.
510(k) number
K240544
Product code
QFQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-13
Date received
2024-02-27
Regulation
876.5982
Classification name
Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Ruthie Amir
Address
17 Hatochen St. Caesarea IL 3079892 3079892

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QFQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K230133PlenityGelesis, Inc.2024-01-19
DEN180060PlenityGelesis, Inc.2019-04-12