Cleared Special

VivAer Stylus

K200300 · Aerin Medical, Inc. · Ear, Nose, Throat

Apr 2020

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K200300 is an FDA 510(k) clearance for the VivAer Stylus, a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Aerin Medical, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on April 13, 2020, 67 days after receiving the submission on February 6, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K200300 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2020
Decision Date	April 13, 2020
Days to Decision	67 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
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).