PreXion3D Expedition
K-Number: K232166 · 2023-09-08
ApplicantPrexion Corporation
Decision Date2023-09-08
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PreXion3D Expedition is a medical device manufactured by Prexion Corporation. It received FDA 510(k) clearance on 2023-09-08 under approval number K232166. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PreXion3D Expedition?
PreXion3D Expedition is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Prexion Corporation. The 510(k) number is K232166.
When was PreXion3D Expedition approved by the FDA?
PreXion3D Expedition received FDA 510(k) clearance on 2023-09-08, under approval number K232166.
What company makes PreXion3D Expedition?
PreXion3D Expedition is manufactured by Prexion Corporation.
What is the FDA product code for PreXion3D Expedition?
The FDA product code for PreXion3D Expedition is OAS.
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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.