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FDA 510(k)

Single-use Flexible Ureteroscope

K-Number: K250785 · 2025-05-06

ApplicantHunan Vathin Medical Instrument Co., Ltd.
Decision Date2025-05-06
Product CodeFGB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Single-use Flexible Ureteroscope is a medical device manufactured by Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-05-06 under approval number K250785. 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 Single-use Flexible Ureteroscope?

Single-use Flexible Ureteroscope is a medical device that received FDA 510(k) clearance on 2025-05-06. It is manufactured by Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K250785.

When was Single-use Flexible Ureteroscope approved by the FDA?

Single-use Flexible Ureteroscope received FDA 510(k) clearance on 2025-05-06, under approval number K250785.

What company makes Single-use Flexible Ureteroscope?

Single-use Flexible Ureteroscope is manufactured by Hunan Vathin Medical Instrument Co., Ltd..

What is the FDA product code for Single-use Flexible Ureteroscope?

The FDA product code for Single-use Flexible Ureteroscope is FGB.

Related Clinical Trials

NCT07296835 Surgical Outcomes and Costs in Using the Shenzhen HugeMed 6.3 French Flexible Ureteroscope RECRUITING NCT07514351 FANS vs CVAC for Medium to Large Stones NOT_YET_RECRUITING

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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