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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Ultrasound System, Gastroenterology-Urology
510(k) Number K251542
Device Name InstaFAN
Applicant
Onepass Medical , Ltd.
1st The Four St.
Katzrin Industrial Park
Katzrin,  IL 1290000
Applicant Contact Jacob Ben Arie
Correspondent
MRC Global
9085 E. Mineral Circle
Centennial,  CO  80112
Correspondent Contact Danielle Besal
Regulation Number876.1500
Classification Product Code
ODG  
Subsequent Product Code
FCG  
Date Received05/20/2025
Decision Date 07/18/2025
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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