FDA 510(k)

一次性導引器 KDNG00

K 號：K180970 · 2018-07-10

申請人Koelis

決定日期2018-07-10

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

Disposable guides KDNG00 is the device name listed in this FDA 510(k) record. The listed applicant is Koelis. It received FDA 510(k) clearance on 2018-07-10 under 510(k) number K180970. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Disposable guides KDNG00?

Disposable guides KDNG00 is a medical device that received FDA 510(k) clearance on 2018-07-10. The listed applicant is Koelis. The 510(k) number is K180970.

When did Disposable guides KDNG00 receive FDA 510(k) clearance?

Disposable guides KDNG00 received FDA 510(k) clearance on 2018-07-10, under 510(k) number K180970.

Who is the listed applicant for Disposable guides KDNG00?

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

What is the FDA product code for Disposable guides KDNG00?

The FDA product code for Disposable guides KDNG00 is ITX.

其他以 Koelis 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。

K171040可重用導引範圍（會陰範圍、指甲範圍、CON-LEAD範圍和LIN-LEAD範圍）以及STeady PRO範圍 K170521TRINITY/3D 前列腺套件 K160357TRINITY

相關器械（代碼：ITX）

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。

K260114Align® 覆蓋及墊材導引工具CIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm Corporation K254143EM-TECH 靜脈式超音波探頭帶EM-TECH Solutions, Inc.K260161SmartGuide 一次性導向器和網格UC-CARE , Ltd.K262474ND針導引系統Accurate Access, LLC K261014Accuro® 3S Needle Guide KitRivanna Medical, 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。