FDA 510(k)

Echotip Ultra 結構內視鏡高解析度超聲針，Echotip Procore 結構內視鏡高解析度超聲針吸組織切片

K 號：K160229 · 2016-03-21

決定日期2016-03-21

產品代碼FCG

諮詢委員會GU

決定相當於

器材摘要

Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ireland, Ltd.. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K160229. The device is classified under product code FCG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle?

Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is Cook Ireland, Ltd.. The 510(k) number is K160229.

When did Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle receive FDA 510(k) clearance?

Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle received FDA 510(k) clearance on 2016-03-21, under 510(k) number K160229.

Who is the listed applicant for Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle?

FDA 510(k) 記錄將 Cook Ireland, Ltd. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle?

The FDA product code for Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle is FCG.