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FDA 510(k)

UroNav 4

K-Number: K250800 · 2025-06-05

ApplicantPhilips DS North America, LLC
Decision Date2025-06-05
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UroNav 4 is a medical device manufactured by Philips DS North America, LLC. It received FDA 510(k) clearance on 2025-06-05 under approval number K250800. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UroNav 4?

UroNav 4 is a medical device that received FDA 510(k) clearance on 2025-06-05. It is manufactured by Philips DS North America, LLC. The 510(k) number is K250800.

When was UroNav 4 approved by the FDA?

UroNav 4 received FDA 510(k) clearance on 2025-06-05, under approval number K250800.

What company makes UroNav 4?

UroNav 4 is manufactured by Philips DS North America, LLC.

What is the FDA product code for UroNav 4?

The FDA product code for UroNav 4 is LLZ.

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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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