ORiGO System
K-Number: K213697 · 2022-10-31
ApplicantBien-Air Surgery SA
Decision Date2022-10-31
Product CodeHBC
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ORiGO System is a medical device manufactured by Bien-Air Surgery SA. It received FDA 510(k) clearance on 2022-10-31 under approval number K213697. The device is classified under product code HBC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ORiGO System?
ORiGO System is a medical device that received FDA 510(k) clearance on 2022-10-31. It is manufactured by Bien-Air Surgery SA. The 510(k) number is K213697.
When was ORiGO System approved by the FDA?
ORiGO System received FDA 510(k) clearance on 2022-10-31, under approval number K213697.
What company makes ORiGO System?
ORiGO System is manufactured by Bien-Air Surgery SA.
What is the FDA product code for ORiGO System?
The FDA product code for ORiGO System is HBC.
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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.