FDA 510(k)

恩科爾乳房組織切片探針及灌洗管

K 號：K210654 · 2021-03-31

決定日期2021-03-31

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

EnCor Breast Biopsy Probe with Rinse Tube is the device name listed in this FDA 510(k) record. The listed applicant is Senorx, Inc.. It received FDA 510(k) clearance on 2021-03-31 under 510(k) number K210654. 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 EnCor Breast Biopsy Probe with Rinse Tube?

EnCor Breast Biopsy Probe with Rinse Tube is a medical device that received FDA 510(k) clearance on 2021-03-31. The listed applicant is Senorx, Inc.. The 510(k) number is K210654.

When did EnCor Breast Biopsy Probe with Rinse Tube receive FDA 510(k) clearance?

EnCor Breast Biopsy Probe with Rinse Tube received FDA 510(k) clearance on 2021-03-31, under 510(k) number K210654.

Who is the listed applicant for EnCor Breast Biopsy Probe with Rinse Tube?

The FDA 510(k) record lists Senorx, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EnCor Breast Biopsy Probe with Rinse Tube?

The FDA product code for EnCor Breast Biopsy Probe with Rinse Tube is KNW.

其他以 Senorx, 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。

K233220EnCor Enspire™乳頭切片系統（E4115、E4230）；EnCor™乳頭切片驅動器（DRENCOR）；EnCor™ MRI乳頭切片驅動器（DRENCORMR）；EnCor™乳頭切片驅動器探針（ECP017G、ECP017GV、ECP0110G、ECP0110GV、ECP0112G、ECP0112GV）；EnCor™ MRI乳頭切片探針（ECPMR017G、ECPMR0110G、ECPMR0110GBT）K161805EnCor MRI 引導組，EnCor 探針引導組

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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