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)

Medical Shaver System (Morcellator) (YSB-IIIA)

N.º K: K251923 · 2026-01-29

SolicitanteHangzhou Hawk Optical Electronic Instruments Co., Ltd.
Fecha de decisión2026-01-29
Código de productoGCJ
Comité asesorGU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Shaver System (Morcellator) (YSB-IIIA) is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Hawk Optical Electronic Instruments Co., Ltd.. It received FDA 510(k) clearance on 2026-01-29 under 510(k) number K251923. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medical Shaver System (Morcellator) (YSB-IIIA)?

Medical Shaver System (Morcellator) (YSB-IIIA) is a medical device that received FDA 510(k) clearance on 2026-01-29. The listed applicant is Hangzhou Hawk Optical Electronic Instruments Co., Ltd.. The 510(k) number is K251923.

When did Medical Shaver System (Morcellator) (YSB-IIIA) receive FDA 510(k) clearance?

Medical Shaver System (Morcellator) (YSB-IIIA) received FDA 510(k) clearance on 2026-01-29, under 510(k) number K251923.

Who is the listed applicant for Medical Shaver System (Morcellator) (YSB-IIIA)?

The FDA 510(k) record lists Hangzhou Hawk Optical Electronic Instruments Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Shaver System (Morcellator) (YSB-IIIA)?

The FDA product code for Medical Shaver System (Morcellator) (YSB-IIIA) is GCJ.

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: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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.

↑