FDA 510(k)

Video Ureteroscope System

N.º K: K241434 · 2024-10-04

SolicitanteHunan Vathin Medical Instrument Co., Ltd.

Fecha de decisión2024-10-04

Código de productoFGB

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Video Ureteroscope System is the device name listed in this FDA 510(k) record. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2024-10-04 under 510(k) number K241434. The device is classified under product code FGB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Video Ureteroscope System?

Video Ureteroscope System is a medical device that received FDA 510(k) clearance on 2024-10-04. The listed applicant is Hunan Vathin Medical Instrument Co., Ltd.. The 510(k) number is K241434.

When did Video Ureteroscope System receive FDA 510(k) clearance?

Video Ureteroscope System received FDA 510(k) clearance on 2024-10-04, under 510(k) number K241434.

Who is the listed applicant for Video Ureteroscope System?

The FDA 510(k) record lists Hunan Vathin Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Video Ureteroscope System?

The FDA product code for Video Ureteroscope System is FGB.

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Otros registros que enlistan a Hunan Vathin Medical Instrument Co., Ltd. como solicitante

K261637Single-use Flexible Bronchoscope K250232Vathin® Video Bronchoscope System K251599Single-use Ureteral Access Sheath K250785Single-use Flexible Ureteroscope K243117Digital Video Processor K242416Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

Ver todos los 18 dispositivos →

Dispositivos relacionados (Código: FGB)

K261447CVAC® Aspiration SystemCalyxo, Inc.K262488Single-Use Video Flexible Ureterorenoscope (RP-U-C06R9, RP-U-C06R3, RP-U-C06S9, RP-U-C06S3)Guangzhou Red Pine Medical Instrument Co., Ltd.K261153LithoVue Elite Digital Flexible Ureteroscope SystemBoston Scientific Corporation K262552Single-use Flexible Ureteroscope (Single-use Flexible Ureteroscope: SUV-5C-B)Scivita Medical Technology Co., Ltd.K253505Zamenix™ PRoen Surgical, Inc.K260516BubbleView Single-Use Digital Flexible Cystoscope (C38-CS, C38-CRS, C50-C, C50-CR, C50-CB, C50-CBR)MacroLux Medical Technology Co., Ltd.

Fuente oficial

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