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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastroscope And Accessories, Flexible/Rigid
510(k) Number K251041
Device Name GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100
Applicant
Actuated Medical, Inc.
320 Rolling Ridge Drive
Bellefonte,  PA  16823
Applicant Contact Douglas Dillon
Correspondent
Actuated Medical, Inc.
320 Rolling Ridge Drive
Bellefonte,  PA  16823
Correspondent Contact Douglas Dillon
Regulation Number876.1500
Classification Product Code
FDS  
Date Received04/03/2025
Decision Date 10/31/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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