RenaNav Ureteroscope System
K-Number: K223097 · 2023-07-31
ApplicantCenterPoint Systems, LLC
Decision Date2023-07-31
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
RenaNav Ureteroscope System is a medical device manufactured by CenterPoint Systems, LLC. It received FDA 510(k) clearance on 2023-07-31 under approval number K223097. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RenaNav Ureteroscope System?
RenaNav Ureteroscope System is a medical device that received FDA 510(k) clearance on 2023-07-31. It is manufactured by CenterPoint Systems, LLC. The 510(k) number is K223097.
When was RenaNav Ureteroscope System approved by the FDA?
RenaNav Ureteroscope System received FDA 510(k) clearance on 2023-07-31, under approval number K223097.
What company makes RenaNav Ureteroscope System?
RenaNav Ureteroscope System is manufactured by CenterPoint Systems, LLC.
What is the FDA product code for RenaNav Ureteroscope System?
The FDA product code for RenaNav Ureteroscope System is FGB.
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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.