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FDA 510(k)

Disposable Percutaneous Nephrostomy Dilatation Kit

K-Number: K250448 · 2025-07-03

ApplicantShenzhen Trious Medical Technology Co., Ltd.
Decision Date2025-07-03
Product CodeLJE
DecisionSubstantially Equivalent

Device Summary

Disposable Percutaneous Nephrostomy Dilatation Kit is a medical device manufactured by Shenzhen Trious Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under approval number K250448. The device is classified under product code LJE. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Disposable Percutaneous Nephrostomy Dilatation Kit?

Disposable Percutaneous Nephrostomy Dilatation Kit is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Shenzhen Trious Medical Technology Co., Ltd.. The 510(k) number is K250448.

When was Disposable Percutaneous Nephrostomy Dilatation Kit approved by the FDA?

Disposable Percutaneous Nephrostomy Dilatation Kit received FDA 510(k) clearance on 2025-07-03, under approval number K250448.

What company makes Disposable Percutaneous Nephrostomy Dilatation Kit?

Disposable Percutaneous Nephrostomy Dilatation Kit is manufactured by Shenzhen Trious Medical Technology Co., Ltd..

What is the FDA product code for Disposable Percutaneous Nephrostomy Dilatation Kit?

The FDA product code for Disposable Percutaneous Nephrostomy Dilatation Kit is LJE.

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Other Devices by Shenzhen Trious Medical Technology Co., Ltd.

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Related Devices (Code: LJE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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