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FDA 510(k)

Voyant 5mm Fusion Device, Voyant Maryland Fusion Device

K-Number: K193292 · 2019-12-20

ApplicantApplied Medical Resources Corp.
Decision Date2019-12-20
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Voyant 5mm Fusion Device, Voyant Maryland Fusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corp.. It received FDA 510(k) clearance on 2019-12-20 under 510(k) number K193292. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Voyant 5mm Fusion Device, Voyant Maryland Fusion Device?

Voyant 5mm Fusion Device, Voyant Maryland Fusion Device is a medical device that received FDA 510(k) clearance on 2019-12-20. The listed applicant is Applied Medical Resources Corp.. The 510(k) number is K193292.

When did Voyant 5mm Fusion Device, Voyant Maryland Fusion Device receive FDA 510(k) clearance?

Voyant 5mm Fusion Device, Voyant Maryland Fusion Device received FDA 510(k) clearance on 2019-12-20, under 510(k) number K193292.

Who is the listed applicant for Voyant 5mm Fusion Device, Voyant Maryland Fusion Device?

The FDA 510(k) record lists Applied Medical Resources Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Voyant 5mm Fusion Device, Voyant Maryland Fusion Device?

The FDA product code for Voyant 5mm Fusion Device, Voyant Maryland Fusion Device is GEI.

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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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