FDA 510(k)

Gangi-SoftGuard同軸針、Gangi-HydroGuard同軸針

K番号: K181756 · 2018-12-18

決定日2018-12-18

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

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle is the device name listed in this FDA 510(k) record. The listed applicant is Apriomed AB. It received FDA 510(k) clearance on 2018-12-18 under 510(k) number K181756. 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 Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle?

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle is a medical device that received FDA 510(k) clearance on 2018-12-18. The listed applicant is Apriomed AB. The 510(k) number is K181756.

When did Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle receive FDA 510(k) clearance?

Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle received FDA 510(k) clearance on 2018-12-18, under 510(k) number K181756.

Who is the listed applicant for Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle?

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

What is the FDA product code for Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle?

The FDA product code for Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle is FCG.

申請者としてApriomed ABを記載するその他の記録

K193268APrioCore Plus

公式ソース

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