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FDA 510(k)

Video Ureteroscope System

K-Number: K231135 · 2024-01-17

ApplicantHunan Vathin Medical Instrument Co., Ltd.
Decision Date2024-01-17
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Video Ureteroscope System is a medical device manufactured by Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-01-17 under approval number K231135. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Video Ureteroscope System?

Video Ureteroscope System is a medical device that received FDA 510(k) clearance on 2024-01-17. It is manufactured by Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K231135.

When was Video Ureteroscope System approved by the FDA?

Video Ureteroscope System received FDA 510(k) clearance on 2024-01-17, under approval number K231135.

What company makes Video Ureteroscope System?

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

What is the FDA product code for Video Ureteroscope System?

The FDA product code for Video Ureteroscope System is FGB.

Related Clinical Trials

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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: FGB)

K172098Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K171076Medical Video Endoscope SystemZhuhai Pusen Medical Technology Co., Ltd. K181977WiScope Digital Endoscope SystemOTU Medical, Inc. K180367Ureterorenoscope SystemShanghai AnQing Medical Instrument Co., Ltd. K172246OLYMPUS URF-V2/V2ROlympus Medical Systems Corp. K172298OLYMPUS URF-P6/P6ROlympus Medical Systems Corp.

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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