FDA 510(k)

Gangi-SoftGuard 同軸針，Gangi-HydroGuard 同軸針

K 號：K181756 · 2018-12-18

決定日期2018-12-18

產品代碼FCG

諮詢委員會GU

決定相當於

器材摘要

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.

常見問題

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.

其他以 Apriomed AB 為申請人之記錄

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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。

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官方來源

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