Cleared Traditional

Vathin Video Bronchoscope System

K213635 · Hunan Vathin Medical Instrument Co., Ltd. · Ear, Nose, Throat

Feb 2022

Decision

103d

Days

Class 2

Risk

About This 510(k) Submission

K213635 is an FDA 510(k) clearance for the Vathin Video Bronchoscope System, a Bronchoscope (flexible Or Rigid) (Class II — Special Controls, product code EOQ), submitted by Hunan Vathin Medical Instrument Co., Ltd. (Xiangtan, CN). The FDA issued a Cleared decision on February 28, 2022, 103 days after receiving the submission on November 17, 2021. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K213635 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2021
Decision Date	February 28, 2022
Days to Decision	103 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Statement

Device Classification

Product Code	EOQ — Bronchoscope (flexible Or Rigid)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4680
Definition	A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. 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).