Plenity®

Basic Information

• Brand Name: Plenity®
• Primary DI: 08055162880078
• Version / Model: MC0855
• Company Name: GELESIS SRL
• Labeler DUNS: 430027070
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 56
• Record Status: Published
• Publish Date: 2026-01-14
• Public Version: 1
• Public Version Date: 2026-01-22
• Public Version Status: New
• Public Device Record Key: 4a2a6722-10cf-4425-990d-d050fb5d2ea2

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
QFQ	Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss	Gastroenterology, Urology	876.5982	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48146	Ingested gastric satiety device	An 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	08055162880009	GS1
Primary	08055162880078	GS1

Premarket Submissions

Submission Number	Supplement Number
K230133	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius