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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K250994
Device Name ClearTip FNA and FNB Types
Applicant
Finemedix Co., Ltd.
140-9, Yuram-Ro, Dong-Gu
Daegu,  KR 41059
Applicant Contact Priscilla Chung
Correspondent
LK Consulting Group USA, Inc.
18881 Von Karman Ave.
Suite 160
Irvine,  CA  92612
Correspondent Contact Priscilla Chung
Regulation Number876.1075
Classification Product Code
FCG  
Date Received04/01/2025
Decision Date 08/21/2025
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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