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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 K261196
Device Name Promisemed VeriEcto Automatic Biopsy Needles
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
#1388 Cangxing St., Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Zearou Yang
Correspondent
Promisemed Hangzhou Meditech Co., Ltd.
#1388 Cangxing St., Cangqian Community, Yuhang District
Hangzhou City,  CN 311121
Correspondent Contact Zearou Yang
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/13/2026
Decision Date 05/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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