Cleared Traditional

MonoStereo

K234096 · Medicaltek Co., Ltd. · Ear, Nose, Throat

Sep 2024

Decision

268d

Days

Class 2

Risk

About This 510(k) Submission

K234096 is an FDA 510(k) clearance for the MonoStereo, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Medicaltek Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on September 19, 2024, 268 days after receiving the submission on December 26, 2023. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K234096 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 26, 2023
Decision Date	September 19, 2024
Days to Decision	268 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
Definition	If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).