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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Automatic Carbon-Dioxide For Endoscope
510(k) Number K262152
Device Name VS-370CF, VS-370CT
Applicant
VISION MEDICAL Co., Ltd.
106, Hyoseo-Ro, Gyeyang-Gu
3f
Incheon,  KR 13217
Applicant Contact Ham Ui-Seong
Correspondent
Third Party Review Group, LLC
1887 Whitney Mesa Dr.
Suite 1960
Henderson,  NV  89014
Correspondent Contact DAVE YUNGVIRT
Regulation Number876.1500
Classification Product Code
FCX  
Date Received06/25/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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