FDA 510(k)

Mammotome AutoCore™ 单次插入式活检系统

K号: K243095 · 2024-10-29

决定日期2024-10-29

产品代码KNW

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决定实质等同

器械摘要

Mammotome AutoCore™ Single Insertion Core Biopsy System is the device name listed in this FDA 510(k) record. The listed applicant is Devicor Medical Products, Inc.. It received FDA 510(k) clearance on 2024-10-29 under 510(k) number K243095. 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 Mammotome AutoCore™ Single Insertion Core Biopsy System?

Mammotome AutoCore™ Single Insertion Core Biopsy System is a medical device that received FDA 510(k) clearance on 2024-10-29. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K243095.

When did Mammotome AutoCore™ Single Insertion Core Biopsy System receive FDA 510(k) clearance?

Mammotome AutoCore™ Single Insertion Core Biopsy System received FDA 510(k) clearance on 2024-10-29, under 510(k) number K243095.

Who is the listed applicant for Mammotome AutoCore™ Single Insertion Core Biopsy System?

The FDA 510(k) record lists Devicor Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mammotome AutoCore™ Single Insertion Core Biopsy System?

The FDA product code for Mammotome AutoCore™ Single Insertion Core Biopsy System is KNW.

列明Devicor Medical Products, Inc.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。

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 K253761HydroMARK™ Plus 乳腺活检位点标记（蜻蜓形状）；HydroMARK™ Plus 乳腺活检位点标记（蜂鸟形状）K240527HydroMARK™ Plus 乳腺活检位点标记（蜂鸟形状）(4010-02-15-T6)K232615LumiMARK™ 活检部位标记 (LM0215T (郁金香形状)); LumiMARK™ 活检部位标记 (LM0215L (莲花形状)); LumiMARK™ 活检部位标记 (LM0215R (玫瑰形状))K221961HydroMARK Plus 乳腺活检位点标记 K212158HydroMARK 乳腺活检位点标记

查看所有 14 个设备 →

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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