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FDA 510(k)

LumiMARK™ 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））

K 號：K232615 · 2024-01-12

申請人Devicor Medical Products, Inc.
決定日期2024-01-12
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

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) 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 2024-01-12 under 510(k) number K232615. 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 LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))?

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) is a medical device that received FDA 510(k) clearance on 2024-01-12. The listed applicant is Devicor Medical Products, Inc.. The 510(k) number is K232615.

When did LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) receive FDA 510(k) clearance?

LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) received FDA 510(k) clearance on 2024-01-12, under 510(k) number K232615.

Who is the listed applicant for LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))?

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 LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape))?

The FDA product code for LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Biopsy Site Marker (LM0215R (Rose shape)) is NEU.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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)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 EndoscopyK252892SCOUT 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

在 FDA 資料庫中查看 →

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