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 a medical device manufactured by Invivo Corporation. It received FDA 510(k) clearance on 2019-12-27 under approval 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. It is manufactured by Invivo Corporation. The 510(k) number is K193403.
When was UroNav System approved by the FDA?
UroNav System received FDA 510(k) clearance on 2019-12-27, under approval number K193403.
What company makes UroNav System?
UroNav System is manufactured by Invivo Corporation.
What is the FDA product code for UroNav System?
The FDA product code for UroNav System 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.