Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
Device Classification Under Section 513(f)(2)(De Novo)
FDA Home
Medical Devices
Databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
Back to Search Results
Device Classification Name
ingested, transient, space occupying device for weight management and/or weight loss
De Novo Number
DEN180060
Device Name
Plenity
Requester
gelesis, inc.
501 boylston street, suite 6102
boston, MA 02116
Contact
eyal ron
Regulation Number
876.5982
Classification Product Code
QFQ
Date Received
11/15/2018
Decision Date
04/12/2019
Decision
granted (DENG)
Classification Advisory Committee
Gastroenterology/Urology
Review Advisory Committee
Gastroenterology/Urology
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Direct
-
-