Not Cleared Direct

DEN180060 - Plenity (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN180060 · Gelesis, Inc. · Gastroenterology & Urology device
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Apr 2019
Decision
148d
Days
Class 2
Risk

DEN180060 is an FDA 510(k) submission (not cleared) 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 Not Cleared (DENG) decision on April 12, 2019 after a review of 148 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Gastroenterology & Urology review framework.

View all Gelesis, Inc. devices

Submission Details

510(k) Number DEN180060 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 15, 2018
Decision Date April 12, 2019
Days to Decision 148 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 130d · This submission: 148d
Pathway characteristics

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.