FDA 510(k)

デクセラ・マイクロカッター30 ブルー・リロード、デクセラ・マイクロカッター30 カーブドチップブルー・リロード、デクセラ・マイクロカッター30 ホワイト・リロード、デクセラ・マイクロカッター30 カーブドチップホワイト・リロード

K番号: K171561 · 2017-08-28

決定日2017-08-28

製品コードGDW

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is the device name listed in this FDA 510(k) record. The listed applicant is Dextera Surgical, Inc.. It received FDA 510(k) clearance on 2017-08-28 under 510(k) number K171561. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is a medical device that received FDA 510(k) clearance on 2017-08-28. The listed applicant is Dextera Surgical, Inc.. The 510(k) number is K171561.

When did Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload receive FDA 510(k) clearance?

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload received FDA 510(k) clearance on 2017-08-28, under 510(k) number K171561.

Who is the listed applicant for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

The FDA 510(k) record lists Dextera Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload?

The FDA product code for Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload is GDW.

公式ソース

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医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：GDW）

公式ソース