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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Piston
510(k) Number K253747
Device Name Disposable Pen Injector (KXYC-03C02, KXYC-03A03)
Applicant
Jiangsu Enjosim Medical Technology Co., Ltd.
#96 Dong'An Rd., Anzhen, Xishan District
Wu Xi,  CN 214104
Applicant Contact Hao Yu
Correspondent
Elite Medical Technology Co., Ltd.
Rm. 102, # 30, Ln. 3188, Xiupu Rd., Pudong New District
Shanghai,  CN 201315
Correspondent Contact Ryan Li
Regulation Number880.5860
Classification Product Code
FMF  
Date Received11/25/2025
Decision Date 08/14/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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