UroNav (Version 3.0)
K-Number: K182561 · 2018-10-19
ApplicantInvivo Corporation
Decision Date2018-10-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
UroNav (Version 3.0) is a medical device manufactured by Invivo Corporation. It received FDA 510(k) clearance on 2018-10-19 under approval number K182561. 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 (Version 3.0)?
UroNav (Version 3.0) is a medical device that received FDA 510(k) clearance on 2018-10-19. It is manufactured by Invivo Corporation. The 510(k) number is K182561.
When was UroNav (Version 3.0) approved by the FDA?
UroNav (Version 3.0) received FDA 510(k) clearance on 2018-10-19, under approval number K182561.
What company makes UroNav (Version 3.0)?
UroNav (Version 3.0) is manufactured by Invivo Corporation.
What is the FDA product code for UroNav (Version 3.0)?
The FDA product code for UroNav (Version 3.0) 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.