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510(k) K230133

Device
Plenity
Applicant
Gelesis, Inc.
510(k) number
K230133
Product code
QFQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-19
Date received
2023-01-17
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
Yverre Bobay
Address
501 Boyston St., Suite 6102 Boston MA US 02116 02116

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
K240544EpitomeeEpitomee Medical , Ltd.2024-09-13
DEN180060PlenityGelesis, Inc.2019-04-12