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510(k) K250448

Disposable Percutaneous Nephrostomy Dilatation Kit by Shenzhen Trious Medical Technology Co., Ltd. — Product Code LJE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
February 18, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Nephrostomy
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type

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