FDA 510(k)

Mammotome AutoCore™ 單次插入核心針吸組織切片系統

K 號：K243095 · 2024-10-29

決定日期2024-10-29

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Devicor Medical Products, Inc. 為申請人之記錄

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K260365Mammotome Prima™ MR雙真空輔助乳房組織切片系統控制模組；Mammotome Prima™ MR雙真空輔助乳房組織切片系統一次性探針，8號；Mammotome Prima™ MR雙真空輔助乳房組織切片系統一次性定位組，8號；Mammotome Prima™ MR雙真空輔助乳房組織切片系統腳踏開關；Mammotome Prima™ MR雙真空輔助乳房組織切片系統可重用托盤；Mammotome Prima™ MR雙真空輔助乳房組織切片系統電池充電器 K253761HydroMARK™ Plus 乳癌切片位置標記器（龍飛形狀）；HydroMARK™ Plus 乳癌切片位置標記器（蜂鳥形狀）K240527HydroMARK™ Plus 乳癌切片位置標記器（蜂鳥形狀）(4010-02-15-T6)K232615LumiMARK™ 結石部位標記器（LM0215T（郁金香形））；LumiMARK™ 結石部位標記器（LM0215L（蓮花形））；LumiMARK™ 結石部位標記器（LM0215R（玫瑰形））K221961HydroMARK Plus 乳癌切片位置標記器 K212158HydroMARK 乳癌切片位置標記器

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相關器械（代碼：KNW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260517自動核心針吸組織切片儀Zhejiang Curaway Medical Technology Co., Ltd.K262571EnCor EnCompass™ 乳癌切片及組織移除系統Bard Peripheral Vascular, Inc.K262792Brevera 結石系統搭配 CorLumina 圖像技術（BREVDISP09）Hologic, Inc.K260572骨髓馬克士曼Medimetrix, LLC K261196Promisemed VeriEcto 自動切片針Promisemed Hangzhou Meditech Co., Ltd.K260365Mammotome Prima™ MR雙真空輔助乳房組織切片系統控制模組；Mammotome Prima™ MR雙真空輔助乳房組織切片系統一次性探針，8號；Mammotome Prima™ MR雙真空輔助乳房組織切片系統一次性定位組，8號；Mammotome Prima™ MR雙真空輔助乳房組織切片系統腳踏開關；Mammotome Prima™ MR雙真空輔助乳房組織切片系統可重用托盤；Mammotome Prima™ MR雙真空輔助乳房組織切片系統電池充電器Devicor Medical Products, Inc.

官方來源

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