Cleared Special

Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)

K222284 · Applied Medical Resources Corporation · General & Plastic Surgery

Oct 2022

Decision

74d

Days

Class 2

Risk

About This 510(k) Submission

K222284 is an FDA 510(k) clearance for the Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214), a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Applied Medical Resources Corporation (Rancho Santa, US). The FDA issued a Cleared decision on October 14, 2022, 74 days after receiving the submission on August 1, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K222284 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2022
Decision Date	October 14, 2022
Days to Decision	74 days
Submission Type	Special
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).