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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K231254
Device Name GripTract-GI Endoscopic Tissue Manipulator
Applicant
Actuated Medical, Inc.
320 Rolling Ridge Dr.
Bellefonte,  PA  16823
Applicant Contact Douglas R. Dillon
Correspondent
Actuated Medical, Inc.
320 Rolling Ridge Dr.
Bellefonte,  PA  16823
Correspondent Contact Douglas R. Dillon
Regulation Number876.1500
Classification Product Code
FDF  
Date Received05/01/2023
Decision Date 11/03/2023
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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