FDA 510(k)

歐布萊恩超聽導管設備組，庫克SP管導管設備組

K 號：K182066 · 2018-10-30

決定日期2018-10-30

產品代碼KOB

諮詢委員會GU

決定Unknown

器材摘要

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K182066. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set?

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Cook Incorporated. The 510(k) number is K182066.

When did O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set receive FDA 510(k) clearance?

O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182066.

Who is the listed applicant for O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set?

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

What is the FDA product code for O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set?

The FDA product code for O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set is KOB.

其他以 Cook Incorporated 為申請人之記錄

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相關器械（代碼：KOB）

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。

K240514AMT 低輪廓會陰導尿管與引流套件Applied Medical Technology, Inc.K181097庫克膀胱造口導尿管組合Cook Incorporated K182709一步式會陰導入器Cook Incorporated

官方來源

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