FDA 510(k)

Echotip Ultra 内経性高解像度超音波針、Echotip Procore 内経性高解像度超音波生検針

K番号: K160229 · 2016-03-21

決定日2016-03-21

製品コードFCG

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定大幅同等

医療機器の概要

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.

よくある質問

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)レコードでは、Cook Ireland, Ltd.が申請者として記載されています。ただし、これ自体で装置製造業者であることを確認することはできません。

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.