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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Access Overtube, Gastroenterology-Urology
510(k) Number K250585
Device Name LumenaTM Ureteral Access Sheath
Applicant
Cathegenix (Xiamen) Co., Ltd.
Rm. 605-2a, #37 Banshang, Bldg. 2,
Torch Hi-Tech Zone, P.R.
Xiamen,  CN 361000
Applicant Contact Deyuan Zheng
Correspondent
Cathegenix (Xiamen) Co., Ltd.
Rm. 605-2a, #37 Banshang, Bldg. 2,
Torch Hi-Tech Zone, P.R.
Xiamen,  CN 361000
Correspondent Contact Deyuan Zheng
Regulation Number876.1500
Classification Product Code
FED  
Date Received02/27/2025
Decision Date 06/27/2025
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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