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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Video Imaging System / Software Component For Real Time Video Augmentation
510(k) Number K253984
Device Name Instrument Exit Point on Touch Surgery™ Aide
Applicant
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Applicant Contact Atbin Malayeri
Correspondent
Covidien, LLC
15 Hampshire St.
Mansfield,  MA  02048
Correspondent Contact Atbin Malayeri
Regulation Number876.1500
Classification Product Code
SFE  
Subsequent Product Code
QZB  
Date Received12/12/2025
Decision Date 06/04/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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