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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K243296
Device Name Disposable Biopsy Needle
Applicant
Carbon (Shenzhen) Medical Device Co., Ltd.
Rm. 203, Bldg. B, 5# Skyworth Innovation Vally, # 1
Tangtou  Rd., Tangtou Community, Shiyan St., Bao'An Dist
Shenzhen,  CN 518102
Applicant Contact Min Ye
Correspondent
Linnwell International Certification Consulting Co., Ltd.
First Floor, Bldg. 1, # 333 Wanfang Rd.,
Minhang District
Shanghai,  CN 201112
Correspondent Contact Jishan Jin
Regulation Number876.1075
Classification Product Code
KNW  
Date Received10/18/2024
Decision Date 07/11/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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