PreXion3D Explorer PRO
K-Number: K221525 · 2022-07-22
ApplicantPrexion Corporation
Decision Date2022-07-22
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
PreXion3D Explorer PRO is a medical device manufactured by Prexion Corporation. It received FDA 510(k) clearance on 2022-07-22 under approval number K221525. 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 Explorer PRO?
PreXion3D Explorer PRO is a medical device that received FDA 510(k) clearance on 2022-07-22. It is manufactured by Prexion Corporation. The 510(k) number is K221525.
When was PreXion3D Explorer PRO approved by the FDA?
PreXion3D Explorer PRO received FDA 510(k) clearance on 2022-07-22, under approval number K221525.
What company makes PreXion3D Explorer PRO?
PreXion3D Explorer PRO is manufactured by Prexion Corporation.
What is the FDA product code for PreXion3D Explorer PRO?
The FDA product code for PreXion3D Explorer PRO 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.