FDA 510(k)

MECRON 穿刺針システム

K番号: K172213 · 2017-10-23

決定日2017-10-23

製品コードHWC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

MECRON Cannulated Screw System is the device name listed in this FDA 510(k) record. The listed applicant is Merete GmbH. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K172213. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the MECRON Cannulated Screw System?

MECRON Cannulated Screw System is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Merete GmbH. The 510(k) number is K172213.

When did MECRON Cannulated Screw System receive FDA 510(k) clearance?

MECRON Cannulated Screw System received FDA 510(k) clearance on 2017-10-23, under 510(k) number K172213.

Who is the listed applicant for MECRON Cannulated Screw System?

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

What is the FDA product code for MECRON Cannulated Screw System?

The FDA product code for MECRON Cannulated Screw System is HWC. This falls under the Cardiovascular category.

申請者としてMerete GmbHを記載するその他の記録

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