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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 K232028
Device Name Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100); Q Base Reusable Base Unit (Q-100)
Applicant
IQ Endoscopes Limited
Basepoint Business Centre, Riverside Court Beaufort Park Way
Chepstow,  GB NP16 5UH
Applicant Contact Chris Jenkins
Correspondent
IQ Endoscopes Limited
Basepoint Business Centre, Riverside Court Beaufort Park Way
Chepstow,  GB NP16 5UH
Correspondent Contact Chris Jenkins
Regulation Number876.1500
Classification Product Code
FDS  
Subsequent Product Code
FET  
Date Received07/07/2023
Decision Date 11/17/2023
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
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