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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 K242325
Device Name GripTract-GI Endoscopic Tissue Manipulator Lower GI Models
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
FDF  
Date Received08/06/2024
Decision Date 10/04/2024
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
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