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FDA 510(k)

PreXion3D Explorer

K-Number: K190320 · 2019-04-15

ApplicantPrexion Corporation
Decision Date2019-04-15
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PreXion3D Explorer is the device name listed in this FDA 510(k) record. The listed applicant is Prexion Corporation. It received FDA 510(k) clearance on 2019-04-15 under 510(k) number K190320. 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?

PreXion3D Explorer is a medical device that received FDA 510(k) clearance on 2019-04-15. The listed applicant is Prexion Corporation. The 510(k) number is K190320.

When did PreXion3D Explorer receive FDA 510(k) clearance?

PreXion3D Explorer received FDA 510(k) clearance on 2019-04-15, under 510(k) number K190320.

Who is the listed applicant for PreXion3D Explorer?

The FDA 510(k) record lists Prexion Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PreXion3D Explorer?

The FDA product code for PreXion3D Explorer is OAS.

Other records listing Prexion Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232166PreXion3D ExpeditionK222150PreXion3D ExpeditionK221525PreXion3D Explorer PROK203784PreXion3D Explorer PROK193329PreXion3D Explorer EXK181983PreXion 3D Excelsior

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Related Devices (Code: 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.

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