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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 K183289
Device Name ClearGrasp Snare
Applicant
Finemedix Co., Ltd.
60, Maeyeo-ro, Dong-gu
Daegu,  KR 41065
Applicant Contact Hee Kyung Kwon
Correspondent
Withus Group Inc
106 Superior
Irvine,  CA  92620
Correspondent Contact April Lee
Regulation Number876.4300
Classification Product Code
FDI  
Date Received11/26/2018
Decision Date 03/06/2019
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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