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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stent, Ureteral
510(k) Number K251469
Device Name Endura™ Ureteral Stent and Stent Set
Applicant
Cathegenix (Xiamen) Co., Ltd.
Rm. 605-2a, #37 Banshang, Bldg. 2, Torch Hi-Tech Zone
Xiamen,  CN 361000
Applicant Contact Deyuan Zheng
Correspondent
Cathegenix (Xiamen) Co., Ltd.
Rm. 605-2a, #37 Banshang, Bldg. 2, Torch Hi-Tech Zone
Xiamen,  CN 361000
Correspondent Contact Deyuan Zheng
Regulation Number876.4620
Classification Product Code
FAD  
Date Received05/13/2025
Decision Date 12/19/2025
Decision Substantially Equivalent - Kit (SESK)
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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