Cleared Traditional

RHIN1 Stylus

K192471 · Aerin Medical, Inc. · Ear, Nose, Throat

Dec 2019

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K192471 is an FDA 510(k) clearance for the RHIN1 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 December 20, 2019, 101 days after receiving the submission on September 10, 2019. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K192471 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 2019
Decision Date	December 20, 2019
Days to Decision	101 days
Submission Type	Traditional
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).