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FDA 510(k)

UroNav System

K-Number: K193403 · 2019-12-27

ApplicantInvivo Corporation
Decision Date2019-12-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

UroNav System is the device name listed in this FDA 510(k) record. The listed applicant is Invivo Corporation. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K193403. 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 System?

UroNav System is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Invivo Corporation. The 510(k) number is K193403.

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

UroNav System received FDA 510(k) clearance on 2019-12-27, under 510(k) number K193403.

Who is the listed applicant for UroNav System?

The FDA 510(k) record lists Invivo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UroNav System?

The FDA product code for UroNav System is LLZ.

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Related Devices (Code: 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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