FDA 510(k) Search

K Number

K250448

Device Name

Disposable Percutaneous Nephrostomy Dilatation Kit

Manufacturer

Shenzhen Trious Medical Technology Co., Ltd

Date Cleared

2025-07-03

Product Code

LJE

Regulation Number

N/A

Intended Use

PDF not available yet

Device Description

PDF not available yet

More Information

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Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

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Class Advise Committee

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Third Party Reviewed

Expedited Review

AI/ML (Artificial Intelligence / Machine Learning)

null

Therapeutic

null

Diagnostic

null

SaMD (Software as a Medical Device)

null

IVD (In Vitro Diagnostic)

null

PCCP (Predetermined Change Control Plan) Authorized

null

Overview

null

Summary

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