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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointestinal Tubes With Enteral Specific Connectors
510(k) Number K254170
Device Name Percutaneous Endoscopic Gastrostomy (PEG) Kit
Applicant
Degania Silicone , Ltd.
Degania Silicone Ltd.
Degania Bet,  IL 1513000
Applicant Contact Tal Gafni
Correspondent
Degania Silicone , Ltd.
Degania Silicone Ltd.
Degania Bet,  IL 1513000
Correspondent Contact Tal Gafni
Regulation Number876.5980
Classification Product Code
PIF  
Subsequent Product Code
KNT  
Date Received12/23/2025
Decision Date 03/20/2026
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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