FDA 510(k)

NovaCore 半自动活检仪器

K号: K213232 · 2022-07-01

决定日期2022-07-01

产品代码KNW

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决定实质等同

器械摘要

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.

常见问题

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.

列明Argon Medical Devices为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K230669L-Cath™ 单双腔导管，L-Cath™ 中线导管 K230631Kodiak™ 双端口同轴导引器套装 K213638Traveler 0.038 风针门静脉通路器（TPS001），Traveler 21ga 针门静脉通路套装（TPS002），Traveler 16ga 针门静脉通路套装（TPS003）K213002SCORPION 门静脉通路套装

相关器械（代码：KNW）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K260517自动核心活检仪器Zhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™乳腺活检和组织移除系统Bard Peripheral Vascular, Inc.K262792Brevera活检系统，配备CorLumina成像技术（BREVDISP09）Hologic, Inc.K260572骨髓马克思曼Medimetrix, LLC K261196Promisemed VeriEcto 自动活检针Promisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR 双真空辅助乳腺活检系统控制模块；Mammotome Prima™ MR 双真空辅助乳腺活检系统一次性探头，8号；Mammotome Prima™ MR 双真空辅助乳腺活检系统一次性靶向套件，8号；Mammotome Prima™ MR 双真空辅助乳腺活检系统脚踏开关；Mammotome Prima™ MR 双真空辅助乳腺活检系统可重复使用的托盘；Mammotome Prima™ MR 双真空辅助乳腺活检系统电池充电器Devicor Medical Products, Inc.

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