RootMend MRR
K-Number: K243988 · 2025-03-20
ApplicantRiverpoint Medical, LLC
Decision Date2025-03-20
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
RootMend MRR is a medical device manufactured by Riverpoint Medical, LLC. It received FDA 510(k) clearance on 2025-03-20 under approval number K243988. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the RootMend MRR?
RootMend MRR is a medical device that received FDA 510(k) clearance on 2025-03-20. It is manufactured by Riverpoint Medical, LLC. The 510(k) number is K243988.
When was RootMend MRR approved by the FDA?
RootMend MRR received FDA 510(k) clearance on 2025-03-20, under approval number K243988.
What company makes RootMend MRR?
RootMend MRR is manufactured by Riverpoint Medical, LLC.
What is the FDA product code for RootMend MRR?
The FDA product code for RootMend MRR is MBI.
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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.