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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K220846
Device Name CORE-SNARE
Applicant
Incore Co., Ltd.
11, Hyeoksin-Daero 78-Gil, Dong-Gu
Daegu,  KR 41072
Applicant Contact Jae-Hun Lee
Correspondent
Incore Co., Ltd.
11, Hyeoksin-Daero 78-Gil, Dong-Gu
Daegu,  KR 41072
Correspondent Contact Jae-Hun Lee
Regulation Number876.4300
Classification Product Code
FDI  
Date Received03/23/2022
Decision Date 11/21/2022
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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