FDA 510(k)

Medone Ultra, Medextra

K号: K192101 · 2020-04-02

决定日期2020-04-02

产品代码KNW

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决定实质等同

器械摘要

Medone Ultra, Medextra 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 2020-04-02 under 510(k) number K192101. 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 Medone Ultra, Medextra?

Medone Ultra, Medextra is a medical device that received FDA 510(k) clearance on 2020-04-02. The listed applicant is Medax Srl Unipersonale. The 510(k) number is K192101.

When did Medone Ultra, Medextra receive FDA 510(k) clearance?

Medone Ultra, Medextra received FDA 510(k) clearance on 2020-04-02, under 510(k) number K192101.

Who is the listed applicant for Medone Ultra, Medextra?

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 Medone Ultra, Medextra?

The FDA product code for Medone Ultra, Medextra is KNW.

列明Medax Srl Unipersonale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。

K192099MED-I骨髓穿刺针，MED-S骨髓穿刺针，MED-L骨髓活检和穿刺系统，MED-B骨髓活检系统，MED-J骨髓活检和穿刺系统 K181803Medax活检系统III K172344Medax活检系统II（MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK）

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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