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FDA 510(k)

Vathin® Video Bronchoscope System

K-Number: K250232 · 2025-07-25

ApplicantHunan Vathin Medical Instrument Co., Ltd.
Decision Date2025-07-25
Product CodeEOQ
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Vathin® Video Bronchoscope System is a medical device manufactured by Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-07-25 under approval number K250232. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vathin® Video Bronchoscope System?

Vathin® Video Bronchoscope System is a medical device that received FDA 510(k) clearance on 2025-07-25. It is manufactured by Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K250232.

When was Vathin® Video Bronchoscope System approved by the FDA?

Vathin® Video Bronchoscope System received FDA 510(k) clearance on 2025-07-25, under approval number K250232.

What company makes Vathin® Video Bronchoscope System?

Vathin® Video Bronchoscope System is manufactured by Hunan Vathin Medical Instrument Co., Ltd..

What is the FDA product code for Vathin® Video Bronchoscope System?

The FDA product code for Vathin® Video Bronchoscope System is EOQ.

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Related PubMed Literature

PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025)

Other Devices by Hunan Vathin Medical Instrument Co., Ltd.

K191828Vathin Video Bronchoscope System K221581Single-Use Flexible Rhinolaryngoscope K221580Single-Use Flexible Cystoscope K213635Vathin Video Bronchoscope System K230536Single-use Flexible Rhinolaryngoscope; Digital Video Monitor K230200Single-Use Flexible Ureteroscope

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Related Devices (Code: EOQ)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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