Plenity®

Primary DI
08055162880078
Brand
Plenity®
Company
GELESIS SRL
Model
MC0855
Device description
Plenity is a porcine gelatin capsule that contains a hydrogel powder (0.75 grams per capsule). Plenity is non-systemic and works directly in the gastrointestinal tract. Plenity hydrogel is made from two naturally derived ingredients, cellulose and citric acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small intestine, to create a sensation of fullness. Plenity is provided non-sterile. The capsules disintegrate in the stomach and release the Plenity particles, which can hydrate up to 100 times their original weight. When fully hydrated, the individual non-clustering Plenity particles from the 2.25 g/dose occupy about a quarter of the average stomach volume. The gel particles mix with ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach and small intestine. Plenity passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. The water is then released and reabsorbed by the body. Plenity particles are eliminated through normal bowel movements; they are not absorbed by the body. Patients consume a dose of three (3) capsules supplied in a single peelable pod. Patients take daily two doses with water, before both lunch and dinner. Plenity pods are supplied in a monthly kit for 28 days (4 weeks) of treatment.
Published
2026-01-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFQIngested, Transient, Space Occupying Device For Weight Management And/Or Weight LossGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230133000PlenityGelesis, Inc.2024-01-19QFQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055162880078PrimaryGS10
08055162880009Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055162880078080551628800788055162880078
08055162880009080551628800098055162880009

GMDN Terms#

Term, Definition table
TermDefinition
Ingested gastric satiety deviceAn orally-administered device intended to facilitate weight loss and treat obesity through appetite control. It is designed to be swallowed before meals to form a viscous gel in the stomach and/or small intestine to increase distention, creating the sensation of fullness and causing the user to eat less. It may additionally slow down intestinal glucose absorption to improve glycaemic control. It typically includes natural or modified fibre which expands after absorbing water; it is available in tablet, capsule, and powder sachet forms. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
430027070
Device count
56
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08055162880009Plenity®MC08552026-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08055162880009Plenity®GELESIS SRLQFQ2026-01-14
27290017914019EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
27290017914026EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
07290017914015EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
07290017914022EpitomeeEPITOMEE MEDICAL LTDQFQ2025-04-22
00860517002665Plenity®GELESIS, INC.QFQ2021-09-01
00860517002672Plenity®GELESIS, INC.QFQ2021-09-01
20860517002638Plenity®GELESIS, INC.QFQ2020-12-09
10860517002631Plenity™ GELESIS, INC.QFQ2020-05-06
00860517002634Plenity™ GELESIS, INC.QFQ2020-05-06
00860517002603Plenity™ GELESIS, INC.QFQ2020-03-09
00860517002627Plenity™ GELESIS, INC.QFQ2020-03-09