FDA 510(k)

HydroMARK™ Plus 乳癌切片位置標記器（蜂鳥形狀）(4010-02-15-T6)

K 號：K240527 · 2024-07-10

決定日期2024-07-10

產品代碼NEU

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) 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 2024-07-10 under 510(k) number K240527. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)?

HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) is a medical device that received FDA 510(k) clearance on 2024-07-10. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K240527.

When did HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) receive FDA 510(k) clearance?

HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) received FDA 510(k) clearance on 2024-07-10, under 510(k) number K240527.

Who is the listed applicant for HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)?

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 HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)?

The FDA product code for HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) is NEU.

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

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。

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）K243095Mammotome AutoCore™ 單次插入核心針吸組織切片系統 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

查看所有 14 項裝置 →

相關器械（代碼：NEU）

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。

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）Devicor Medical Products, Inc.K253888MOLLI 2 系統Stryker Endoscopy K252892SCOUT MD 外科導航系統Merit Medical Systems, Inc.K251989VizMark 預載組織標記設備（VM-0001）Breast-Med, Inc.K251748MammoSTAR 繭組切片位置識別器Carbon Medical Technologies, Inc.K243642UltraCor™ Twirl™ 乳組織標記器Bard Peripheral Vascular, Inc.

官方來源

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