Aviso: Este sitio agrega datos públicos oficiales de la FDA, ClinicalTrials.gov, PubMed y SEC EDGAR solo como referencia general. No constituye asesoramiento médico, diagnóstico, recomendaciones de tratamiento ni asesoramiento de inversión.

FDA 510(k)

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)

N.º K: K252929 · 2026-04-09

SolicitanteAnhui Happiness Workshop Instruments Co., Ltd.
Fecha de decisión2026-04-09
Código de productoFGB
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Happiness Workshop Instruments Co., Ltd.. It received FDA 510(k) clearance on 2026-04-09 under 510(k) number K252929. 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 Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is a medical device that received FDA 510(k) clearance on 2026-04-09. The listed applicant is Anhui Happiness Workshop Instruments Co., Ltd.. The 510(k) number is K252929.

When did Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) receive FDA 510(k) clearance?

Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) received FDA 510(k) clearance on 2026-04-09, under 510(k) number K252929.

Who is the listed applicant for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

The FDA 510(k) record lists Anhui Happiness Workshop Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)?

The FDA product code for Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200) is FGB.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: FGB)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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 CorporationK262552Single-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

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

↑