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Voyant Maryland Fusion device with Single-Step Activation (EB212 +2 more)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222284

by Applied Medical Resources Corporation

Identifiers

510(k) Number
K222284 FDA 510(k)
FDA Product Code
GEI FDA 510(k)
Models / Variants
EB212 FDA 510(k)
EB213 FDA 510(k)
EB214 FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Voyant Maryland Fusion device with Single-Step Activation (EB212 +2 more) by Applied Medical Resources Corporation — Class II — FDA_510K — listed in FDA…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Applied Medical Resources Corporation

Sources (1)

  • FDA 510(k) K222284 24 fields · synced Jun 19, 2026