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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Injection Needle, Gastroenterology-Urology
510(k) Number K240675
Device Name Endoscopic Injection Needles
Applicant
Promisemed Hangzhou Meditech Co., Ltd.
# 1388 Cangxing St., Cangqian Community,Yuhang District
Hangzhou City,  CN 311121
Applicant Contact Yang Zearou
Correspondent
Promisemed Hangzhou Meditech Co., Ltd.
# 1388 Cangxing St., Cangqian Community,Yuhang District
Hangzhou City,  CN 311121
Correspondent Contact Yang Zearou
Regulation Number876.1500
Classification Product Code
FBK  
Date Received03/11/2024
Decision Date 10/04/2024
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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