Cleared Traditional

K230133 - Plenity (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K230133 · Gelesis, Inc. · Gastroenterology & Urology device
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Jan 2024
Decision
367d
Days
Class 2
Risk

K230133 is an FDA 510(k) clearance for the Plenity. Classified as Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss (product code QFQ), Class II - Special Controls.

Submitted by Gelesis, Inc. (Boston, US). The FDA issued a Cleared decision on January 19, 2024 after a review of 367 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5982 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Gelesis, Inc. devices

Submission Details

510(k) Number K230133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2023
Decision Date January 19, 2024
Days to Decision 367 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
237d slower than avg
Panel avg: 130d · This submission: 367d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QFQ Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5982
Definition This Device Is An Ingested Material That Transiently Occupies Space In The Stomach. The Device Passes From The Body Via The Natural Gastrointestinal Tract.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - QFQ Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss

Devices cleared under the same product code (QFQ) and FDA review panel - the closest regulatory comparables to K230133.
Epitomee
K240544 · Epitomee Medical , Ltd. · Sep 2024