Cleared Special

Voyant? Open Fusion Device (EB240/Open Fusion)

K252740 · Applied Medical Resources Corp. · General & Plastic Surgery

Nov 2025

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K252740 is an FDA 510(k) clearance for the Voyant? Open Fusion Device (EB240/Open Fusion), 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 November 4, 2025, 68 days after receiving the submission on August 28, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K252740 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 28, 2025
Decision Date	November 04, 2025
Days to Decision	68 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).