FDA 510(k)

Co-Ablation 系统与无菌 Co-Ablation 探头

K号: K243042 · 2025-01-29

决定日期2025-01-29

产品代码GEH

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决定实质等同

器械摘要

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.

常见问题

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.

列明Hygea Medical Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K233140微波消融设备（Exceed S10U）；无菌微波消融探头（Exact）

相关器械（代码：GEH）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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