Origin
K-Number: K243965 · 2025-08-21
Decision Date2025-08-21
Product CodeSFO
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Origin is a medical device manufactured by Nerv Technology Inc. (D.B.A.) Fluidai Medical. It received FDA 510(k) clearance on 2025-08-21 under approval number K243965. The device is classified under product code SFO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Origin?
Origin is a medical device that received FDA 510(k) clearance on 2025-08-21. It is manufactured by Nerv Technology Inc. (D.B.A.) Fluidai Medical. The 510(k) number is K243965.
When was Origin approved by the FDA?
Origin received FDA 510(k) clearance on 2025-08-21, under approval number K243965.
What company makes Origin?
Origin is manufactured by Nerv Technology Inc. (D.B.A.) Fluidai Medical.
What is the FDA product code for Origin?
The FDA product code for Origin is SFO.
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.