FDA 510(k)

自动活检针BAM，半自动针BIM

K号: K233294 · 2024-06-18

申请人Itp Innovative Tomography Products GmbH

决定日期2024-06-18

产品代码KNW

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决定实质等同

器械摘要

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is the device name listed in this FDA 510(k) record. The listed applicant is Itp Innovative Tomography Products GmbH. It received FDA 510(k) clearance on 2024-06-18 under 510(k) number K233294. 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 Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is a medical device that received FDA 510(k) clearance on 2024-06-18. The listed applicant is Itp Innovative Tomography Products GmbH. The 510(k) number is K233294.

When did Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM receive FDA 510(k) clearance?

Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM received FDA 510(k) clearance on 2024-06-18, under 510(k) number K233294.

Who is the listed applicant for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

The FDA 510(k) record lists Itp Innovative Tomography Products GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM?

The FDA product code for Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM is KNW.

列明Itp Innovative Tomography Products GmbH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。

K222462半自动活检针（BIM 18/20）；半自动活检针（BIM 18.15）；半自动活检针（BIM 18/10）；半自动活检针（BIM 16/20）；半自动活检针（BIM 16/15）；半自动活检针（BIM 16/10）；半自动活检针（BIM 14/20）；半自动活检针（BIM 14/15）；半自动活检针（BIM 14/10）

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.

官方来源

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