FDA 510(k)

NovaCore Semi-Automatic Biopsy Instrument

Número K: K213232 · 2022-07-01

Data da decisão2022-07-01

Código do produtoKNW

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

NovaCore Semi-Automatic Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Devices. It received FDA 510(k) clearance on 2022-07-01 under 510(k) number K213232. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NovaCore Semi-Automatic Biopsy Instrument?

NovaCore Semi-Automatic Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2022-07-01. The listed applicant is Argon Medical Devices. The 510(k) number is K213232.

When did NovaCore Semi-Automatic Biopsy Instrument receive FDA 510(k) clearance?

NovaCore Semi-Automatic Biopsy Instrument received FDA 510(k) clearance on 2022-07-01, under 510(k) number K213232.

Who is the listed applicant for NovaCore Semi-Automatic Biopsy Instrument?

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

What is the FDA product code for NovaCore Semi-Automatic Biopsy Instrument?

The FDA product code for NovaCore Semi-Automatic Biopsy Instrument is KNW.

Ensaios clínicos relacionados

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

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

Outros registros que listam Argon Medical Devices como candidato(a)

K230669L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters K230631Kodiak™ Dual Port Coaxial Introducer Kit K213638Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003)K213002SCORPION Portal Vein Access Set

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.

Fonte oficial

Ver na base de dados da FDA →

Dados provenientes da FDA Open API. Para informações mais recentes e oficiais, consulte sempre o registro oficial.