Plenity

Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss

Gelesis, Inc.

The following data is part of a De Novo classification by Gelesis, Inc. with the FDA for Plenity.

Pre-market Notification Details

DeNovo IDDEN180060
Device Name:Plenity
ClassificationIngested, Transient, Space Occupying Device For Weight Management And/or Weight Loss
Applicant Gelesis, Inc. 501 Boylston Street, Suite 6102 Boston,  MA  02116
ContactEyal Ron
Product CodeQFQ  
CFR Regulation Number876.5982 [🔎]
DecisionGranted (DENG)
Review Advisory BoardGastroenterology/Urology
Classification AdvisoryGastroenterology/Urology
TypeDirect
Date Received2018-11-15
Decision Date2019-04-12
Reclassification Order:Reclassification Order

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00860517002627 DEN180060 000
00860517002634 DEN180060 000

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