FDA 510(k)

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

K番号: K243042 · 2025-01-29

決定日2025-01-29

製品コードGEH

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

Co-Ablation System with Sterile Co-Ablation Probe 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 2025-01-29 under 510(k) number K243042. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Co-Ablation System with Sterile Co-Ablation Probe?

Co-Ablation System with Sterile Co-Ablation Probe is a medical device that received FDA 510(k) clearance on 2025-01-29. The listed applicant is Hygea Medical Technology Co., Ltd.. The 510(k) number is K243042.

When did Co-Ablation System with Sterile Co-Ablation Probe receive FDA 510(k) clearance?

Co-Ablation System with Sterile Co-Ablation Probe received FDA 510(k) clearance on 2025-01-29, under 510(k) number K243042.

Who is the listed applicant for Co-Ablation System with Sterile Co-Ablation Probe?

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 Co-Ablation System with Sterile Co-Ablation Probe?

The FDA product code for Co-Ablation System with Sterile Co-Ablation Probe is GEH.

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

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