Cleared Special

Voyant Maryland Fusion Device

K200598 · Applied Medical Resources Corp. · General & Plastic Surgery

Apr 2020

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K200598 is an FDA 510(k) clearance for the Voyant Maryland Fusion Device, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Applied Medical Resources Corp. (Rancho Santa, US). The FDA issued a Cleared decision on April 8, 2020, 30 days after receiving the submission on March 9, 2020. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K200598 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2020
Decision Date	April 08, 2020
Days to Decision	30 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).