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FDA 510(k)

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)

K-Number: K252412 · 2025-10-31

Decision Date2025-10-31
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) is the device name listed in this FDA 510(k) record. The listed applicant is Applied Medical Resources Corporation. It received FDA 510(k) clearance on 2025-10-31 under 510(k) 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. The listed applicant is Applied Medical Resources Corporation. The 510(k) number is K252412.

When did Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) receive FDA 510(k) clearance?

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

Who is the listed applicant for Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)?

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

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.

Other records listing Applied Medical Resources 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.

View all 28 devices →

Related Devices (Code: GEI)

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.

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.