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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K251178
Device Name Ready to use Nelaton Catheter
Applicant
Jamjoom Fullcare Corporation
#6 Dongshan Rd.
Shaoxing,  CN 312000
Applicant Contact Yinan Song
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Grace Liu
Regulation Number876.5130
Classification Product Code
EZD  
Date Received04/16/2025
Decision Date 01/02/2026
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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