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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ingested, Transient, Space Occupying Device For Weight Management And/Or Weight Loss
510(k) Number K261783
Device Name Plenity-V (MC0979 / GS110)
Applicant
Gelesis SRL
Via Europa 187
Calimera,  IT 73021
Applicant Contact Giorgio Sorcini
Correspondent
Gelesis SRL
Via Europa 187
Calimera,  IT 73021
Correspondent Contact Giorgio Sorcini
Regulation Number876.5982
Classification Product Code
QFQ  
Date Received05/29/2026
Decision Date 10/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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