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510(k) K251469

Endura™ Ureteral Stent and Stent Set by Cathegenix (Xiamen) Co., Ltd. — Product Code FAD

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
December 19, 2025
Date Received
May 13, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Ureteral
Device Class
Class II
Regulation Number
876.4620
Review Panel
GU
Submission Type

Other clearances by Cathegenix (Xiamen) Co., Ltd.

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