FDA 510(k)

マイクロウェーブ消融装置（Exceed S10U）；無菌マイクロウェーブ消融プローブ（Exact）

K番号: K233140 · 2024-01-31

決定日2024-01-31

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

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is the device name listed in this FDA 510(k) record. The listed applicant is Hygea Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-01-31 under 510(k) number K233140. 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 Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is a medical device that received FDA 510(k) clearance on 2024-01-31. The listed applicant is Hygea Medical Technology Co., Ltd.. The 510(k) number is K233140.

When did Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) receive FDA 510(k) clearance?

Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) received FDA 510(k) clearance on 2024-01-31, under 510(k) number K233140.

Who is the listed applicant for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

The FDA 510(k) record lists Hygea Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact)?

The FDA product code for Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) is NEY.

申請者としてHygea Medical Technology Co., Ltd.を記載するその他の記録

K243042無菌コアブレーションプローブ付きコアブレーションシステム

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