FDA 510(k)

Medax Biopsy Systems III

N.º K: K181803 · 2018-10-18

Fecha de decisión2018-10-18

Código de productoKNW

Comité asesorGU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medax Biopsy Systems III is the device name listed in this FDA 510(k) record. The listed applicant is Medax Srl Unipersonale. It received FDA 510(k) clearance on 2018-10-18 under 510(k) number K181803. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Medax Biopsy Systems III?

Medax Biopsy Systems III is a medical device that received FDA 510(k) clearance on 2018-10-18. The listed applicant is Medax Srl Unipersonale. The 510(k) number is K181803.

When did Medax Biopsy Systems III receive FDA 510(k) clearance?

Medax Biopsy Systems III received FDA 510(k) clearance on 2018-10-18, under 510(k) number K181803.

Who is the listed applicant for Medax Biopsy Systems III?

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

What is the FDA product code for Medax Biopsy Systems III?

The FDA product code for Medax Biopsy Systems III is KNW.

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 Medax Srl Unipersonale como solicitante

K192099MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System K192101Medone Ultra, Medextra K172344Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)

Dispositivos relacionados (Código: KNW)

K260517Automatic Core Biopsy InstrumentZhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ Breast Biopsy and Tissue Removal SystemBard Peripheral Vascular, Inc.K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)Hologic, Inc.K260572Marrow MarxmanMedimetrix, LLC K261196Promisemed VeriEcto Automatic Biopsy NeedlesPromisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Probe, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Disposable Targeting Set, 8 gauge; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Foot Switch; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Reusable Tray; Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Battery CharDevicor Medical Products, 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.