FDA 510(k)

UroNav 4

K-Number: K250800 · 2025-06-05

Decision Date2025-06-05

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

UroNav 4 is the device name listed in this FDA 510(k) record. The listed applicant is Philips DS North America, LLC. It received FDA 510(k) clearance on 2025-06-05 under 510(k) 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. The listed applicant is Philips DS North America, LLC. The 510(k) number is K250800.

When did UroNav 4 receive FDA 510(k) clearance?

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

Who is the listed applicant for UroNav 4?

The FDA 510(k) record lists Philips DS North America, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UroNav 4?

The FDA product code for UroNav 4 is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

Official Source

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