FDA 510(k)

NEUWAVE™ ミクロウェーブ消融システムおよびアクセサリー

K番号: K231738 · 2023-11-16

決定日2023-11-16

製品コードNEY

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

NEUWAVE™ Microwave Ablation System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Neuwave Medical, Inc.. It received FDA 510(k) clearance on 2023-11-16 under 510(k) number K231738. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the NEUWAVE™ Microwave Ablation System and Accessories?

NEUWAVE™ Microwave Ablation System and Accessories is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is Neuwave Medical, Inc.. The 510(k) number is K231738.

When did NEUWAVE™ Microwave Ablation System and Accessories receive FDA 510(k) clearance?

NEUWAVE™ Microwave Ablation System and Accessories received FDA 510(k) clearance on 2023-11-16, under 510(k) number K231738.

Who is the listed applicant for NEUWAVE™ Microwave Ablation System and Accessories?

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

What is the FDA product code for NEUWAVE™ Microwave Ablation System and Accessories?

The FDA product code for NEUWAVE™ Microwave Ablation System and Accessories is NEY.

申請者としてNeuwave Medical, Inc.を記載するその他の記録

K232227ABLATE-IQ K220472NEUWAVE ミクロウェーブ消融システムおよびアクセサリー K200081NEUWAVE ミクロウェーブ消融システムおよびアクセサリー K192427消融確認 K173756Certus 140 2.45GHz 消融システム K171022消融確認

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