FDA 510(k)

SUREcore Plus 結構組織切片儀

K 號：K220611 · 2022-12-02

決定日期2022-12-02

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

SUREcore Plus Biopsy Instrument is the device name listed in this FDA 510(k) record. The listed applicant is Uro-1, Inc.. It received FDA 510(k) clearance on 2022-12-02 under 510(k) number K220611. 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 SUREcore Plus Biopsy Instrument?

SUREcore Plus Biopsy Instrument is a medical device that received FDA 510(k) clearance on 2022-12-02. The listed applicant is Uro-1, Inc.. The 510(k) number is K220611.

When did SUREcore Plus Biopsy Instrument receive FDA 510(k) clearance?

SUREcore Plus Biopsy Instrument received FDA 510(k) clearance on 2022-12-02, under 510(k) number K220611.

Who is the listed applicant for SUREcore Plus Biopsy Instrument?

The FDA 510(k) record lists Uro-1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUREcore Plus Biopsy Instrument?

The FDA product code for SUREcore Plus Biopsy Instrument is KNW.

其他以 Uro-1, 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。

K201650VMCore 結構組織針 K180214Repris 膀胱注射系統

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

在 FDA 資料庫中查看 →

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。