FDA 510(k)

GTK一次性針導管

K 號：K170741 · 2017-06-01

決定日期2017-06-01

產品代碼ITX

諮詢委員會RA

決定相當於

器材摘要

GTK Disposable Needle Guides is the device name listed in this FDA 510(k) record. The listed applicant is Geotek Medikal Ltd Sti. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170741. 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 GTK Disposable Needle Guides?

GTK Disposable Needle Guides is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Geotek Medikal Ltd Sti. The 510(k) number is K170741.

When did GTK Disposable Needle Guides receive FDA 510(k) clearance?

GTK Disposable Needle Guides received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170741.

Who is the listed applicant for GTK Disposable Needle Guides?

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

What is the FDA product code for GTK Disposable Needle Guides?

The FDA product code for GTK Disposable Needle Guides is ITX.

其他以 Geotek Medikal Ltd Sti 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。

K223300Estacore-Pro 自動切片針，Geotek 半自動切片針，Maxicore-M 自動切片槍針，Maxicore-M 自動切片針及工具

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

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