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FDA 510(k)

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)

K-Number: K252412 · 2025-10-31

ApplicantApplied Medical Resources Corporation
Decision Date2025-10-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is a medical device manufactured by Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2025-10-31 under approval number K252412. 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® Electrosurgical Generator (EA030/Electrosurgical Generator)?

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is a medical device that received FDA 510(k) clearance on 2025-10-31. It is manufactured by Applied Medical Resources Corporation. The 510(k) number is K252412.

When was Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) approved by the FDA?

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) received FDA 510(k) clearance on 2025-10-31, under approval number K252412.

What company makes Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is manufactured by Applied Medical Resources Corporation.

What is the FDA product code for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

The FDA product code for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) 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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