FDA 510(k)

UltraCor™ Twirl™ 乳組織標記器

K 號：K243642 · 2025-03-24

決定日期2025-03-24

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

UltraCor™ Twirl™ Breast Tissue Marker is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2025-03-24 under 510(k) number K243642. 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 UltraCor™ Twirl™ Breast Tissue Marker?

UltraCor™ Twirl™ Breast Tissue Marker is a medical device that received FDA 510(k) clearance on 2025-03-24. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K243642.

When did UltraCor™ Twirl™ Breast Tissue Marker receive FDA 510(k) clearance?

UltraCor™ Twirl™ Breast Tissue Marker received FDA 510(k) clearance on 2025-03-24, under 510(k) number K243642.

Who is the listed applicant for UltraCor™ Twirl™ Breast Tissue Marker?

FDA 510(k) 記錄將 Bard Peripheral Vascular, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for UltraCor™ Twirl™ Breast Tissue Marker?

The FDA product code for UltraCor™ Twirl™ Breast Tissue Marker is NEU.

其他以 Bard Peripheral Vascular, 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。

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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.K233639SmartClip 安全軟組織標記Elucent Medical, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。