FDA 510(k)

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)

N.º K: K201840 · 2020-11-04

Fecha de decisión2020-11-04

Código de productoGWG

Comité asesorNE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is the device name listed in this FDA 510(k) record. The listed applicant is Rebound Therapeutics. It received FDA 510(k) clearance on 2020-11-04 under 510(k) number K201840. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is a medical device that received FDA 510(k) clearance on 2020-11-04. The listed applicant is Rebound Therapeutics. The 510(k) number is K201840.

When did Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) receive FDA 510(k) clearance?

Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) received FDA 510(k) clearance on 2020-11-04, under 510(k) number K201840.

Who is the listed applicant for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

The FDA 510(k) record lists Rebound Therapeutics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box)?

The FDA product code for Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) is GWG.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Otros registros que enlistan a Rebound Therapeutics como solicitante

K203745AURORA Evacuator +Coag K201637Aurora Evacuator +Coag K191861Aurora Surgiscope System K190075Aurora Evacuator K180372Aurora Evacuator

Dispositivos relacionados (Código: GWG)

K253602Precision S 4K SinuscopeStryker Endoscopy K253679Hydro Irrigation SystemStryker Instruments K243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752SISTEMA DE ENDOSCOPIA DE AURORA® (ASX15/60); SISTEMA DE ENDOSCOPIA DE AURORA® (ASX15/80)Integra LifeSciences Corporation K233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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.