Cleared Traditional

K261783 - Plenity-V (MC0979 / GS110)

K261783 is an FDA 510(k) clearance for Plenity-V (MC0979 / GS110), manufactured by Gelesis SRL. The device is a Class 2 Gastroenterology & Urology device with product code QFQ cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K261783 · Gelesis SRL · Gastroenterology & Urology device
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Oct 2026
Decision
126d
Days
Class 2
Risk

K261783 is an FDA 510(k) clearance for the Plenity-V (MC0979 / GS110). Classified as Ingested, Transient, Space Occupying Device For Weight Management And/or Weight Loss (product code QFQ), Class II - Special Controls.

Submitted by Gelesis SRL (Calimera, IT). The FDA issued a Cleared decision on October 2, 2026 after a review of 126 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 SRL devices

FDA 510(k) Submission Details - K261783

510(k) Number K261783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 2026
Decision Date October 02, 2026
Days to Decision 126 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
5d faster than avg
Panel avg: 131d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QFQ Device Classification - Class 2, Special Controls

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.