FDA 510(k)

Glo-Tip噴射電極導管

K 號：K182319 · 2019-02-01

決定日期2019-02-01

產品代碼OCX

諮詢委員會GU

決定相當於

器材摘要

Glo-Tip Spray Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Wilson-Cook Medical, Inc.. It received FDA 510(k) clearance on 2019-02-01 under 510(k) number K182319. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Glo-Tip Spray Catheter?

Glo-Tip Spray Catheter is a medical device that received FDA 510(k) clearance on 2019-02-01. The listed applicant is Wilson-Cook Medical, Inc.. The 510(k) number is K182319.

When did Glo-Tip Spray Catheter receive FDA 510(k) clearance?

Glo-Tip Spray Catheter received FDA 510(k) clearance on 2019-02-01, under 510(k) number K182319.

Who is the listed applicant for Glo-Tip Spray Catheter?

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

What is the FDA product code for Glo-Tip Spray Catheter?

The FDA product code for Glo-Tip Spray Catheter is OCX.

其他以 Wilson-Cook 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。

K253302Hemospray內視鏡止血器（HEMO-[X])K243568Tesla雙極肛門切開器；Tesla BiCord活動繩 K213356Entuit PEG，Entuit PEGJ K212323Instinct Plus內視鏡夾合器 K201322恩圖伊特鼻腸管輸食管 K200972Hemospray內視鏡止血器

查看所有 32 項裝置 →

相關器械（代碼：OCX）

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。

K251986輔助水管 MAJ-855Olympus Medical Systems Corporation K251997單次使用病理切片閥 (MAJ-1555)Olympus Medical Systems Corporation K242586ArgoCap (200.52)Ovesco Endoscopy AG K241704內視鏡式水泵Hangzhou AGS MedTech Co., Ltd.K242357水壺（MAJ-901）；水壺（MAJ-902）Olympus Medical Systems Corporation K241874吸引針 (2189)Hobbs 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。