FDA 510(k)

Remington醫療股份有限公司自動切割針(NAC)

K 號：K191315 · 2019-07-12

決定日期2019-07-12

產品代碼KNW

諮詢委員會GU

決定相當於

器材摘要

Remington Medical, Inc. Automatic Cutting Needle (NAC) is the device name listed in this FDA 510(k) record. The listed applicant is Remington Medical, Inc.. It received FDA 510(k) clearance on 2019-07-12 under 510(k) number K191315. 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 Remington Medical, Inc. Automatic Cutting Needle (NAC)?

Remington Medical, Inc. Automatic Cutting Needle (NAC) is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Remington Medical, Inc.. The 510(k) number is K191315.

When did Remington Medical, Inc. Automatic Cutting Needle (NAC) receive FDA 510(k) clearance?

Remington Medical, Inc. Automatic Cutting Needle (NAC) received FDA 510(k) clearance on 2019-07-12, under 510(k) number K191315.

Who is the listed applicant for Remington Medical, Inc. Automatic Cutting Needle (NAC)?

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

What is the FDA product code for Remington Medical, Inc. Automatic Cutting Needle (NAC)?

The FDA product code for Remington Medical, Inc. Automatic Cutting Needle (NAC) is KNW.

其他以 Remington Medical, 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。

K251904VascuChek 套件、VascuChek 轨射器、VascuChek 醫學探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-CP-01、VC-SD-01）；VascuChek 套件、VascuChek 轨射器、VascuChek 外科探針、VascuChek 聲音基座（VC-KIT-02、VC-TRX-02、VC-SP-01、VC-SD-01）K241583VascuChek 套件、VascuChek 訊號傳送器、VascuChek 醫學探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-CP-01、VC-CH-01）；VascuChek 套件、VascuChek 訊號傳送器、VascuChek 外科探針、VascuChek 充電器（VC-KIT-01、VC-TRX-01、VC-SP-01、VC-CH-01）K211589VascuChek 套件、VascuChek 訊號傳送器、VascuChek 外科探針、VascuChek 充電器 K212065VascuChek 套件、VascuChek 訊號傳送器、VascuChek 醫學探針、VascuChek 充電器

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。