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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 K250268
Device Name HyperSnap Surgical System (HSS)
Applicant
Hypervision Surgical
London Institute For Healthcare Engineering
100 Lambeth Palace Rd.
London,  GB SE1 7AR
Applicant Contact Jaco Jacobs
Correspondent
Hypervision Surgical
London Institute For Healthcare Engineering
100 Lambeth Palace Rd.
London,  GB SE1 7AR
Correspondent Contact Jaco Jacobs
Regulation Number876.1500
Classification Product Code
SFE  
Subsequent Product Codes
FET   MUD  
Date Received01/30/2025
Decision Date 06/24/2025
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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