FDA 510(k)

HydroMARK 乳癌切片位置標記器

K 號：K170803 · 2017-06-15

決定日期2017-06-15

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 Breast Biopsy Site Markers 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 2017-06-15 under 510(k) number K170803. 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 Breast Biopsy Site Markers?

HydroMARK Breast Biopsy Site Markers is a medical device that received FDA 510(k) clearance on 2017-06-15. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K170803.

When did HydroMARK Breast Biopsy Site Markers receive FDA 510(k) clearance?

HydroMARK Breast Biopsy Site Markers received FDA 510(k) clearance on 2017-06-15, under 510(k) number K170803.

Who is the listed applicant for HydroMARK Breast Biopsy Site Markers?

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 Breast Biopsy Site Markers?

The FDA product code for HydroMARK Breast Biopsy Site Markers 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 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

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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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