Class Class U

Disposable Percutaneous Nephrostomy Dilatation Kit (K250448)

K250448 2025-07-03 Traditional
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Description

Disposable Percutaneous Nephrostomy Dilatation Kit by Shenzhen Trious Medical Technology Co., Ltd., an FDA 510(k) cleared unknown device.

Regulatory Information

Device ClassClass Class U
510(k) NumberK250448
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodeLJE

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Predicate lineage for K250448

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Disposable Percutaneous Nephrostomy Dilatation Kit (K250448) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K170531Ureteral Dilators and Percutaneous Nephrostomy DilatorsColoplast Corp.2017

Trace the full predicate network for K250448

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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