Cleared Traditional

Vathin? Video Bronchoscope System

K250232 · Hunan Vathin Medical Instrument Co., Ltd. · Ear, Nose, Throat

Jul 2025

Decision

179d

Days

Class 2

Risk

About This 510(k) Submission

K250232 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. (Xiang Tan, CN). The FDA issued a Cleared decision on July 25, 2025, 179 days after receiving the submission on January 27, 2025. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4680.

Submission Details

510(k) Number	K250232 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 2025
Decision Date	July 25, 2025
Days to Decision	179 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

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).