Accuro 3S
K-Number: K243937 · 2025-05-23
ApplicantRivanna Medical, Inc.
Decision Date2025-05-23
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Accuro 3S is a medical device manufactured by Rivanna Medical, Inc.. It received FDA 510(k) clearance on 2025-05-23 under approval number K243937. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Accuro 3S?
Accuro 3S is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Rivanna Medical, Inc.. The 510(k) number is K243937.
When was Accuro 3S approved by the FDA?
Accuro 3S received FDA 510(k) clearance on 2025-05-23, under approval number K243937.
What company makes Accuro 3S?
Accuro 3S is manufactured by Rivanna Medical, Inc..
What is the FDA product code for Accuro 3S?
The FDA product code for Accuro 3S is IYO.
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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.