FDA 510(k)

MOVIVA® 混合消融探头

K号: K253915 · 2025-12-18

决定日期2025-12-18

产品代码GEI

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决定实质等同

器械摘要

MOVIVA® Hybrid Ablation Probe is the device name listed in this FDA 510(k) record. The listed applicant is Erbe Elektromedizin GmbH. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K253915. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MOVIVA® Hybrid Ablation Probe?

MOVIVA® Hybrid Ablation Probe is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Erbe Elektromedizin GmbH. The 510(k) number is K253915.

When did MOVIVA® Hybrid Ablation Probe receive FDA 510(k) clearance?

MOVIVA® Hybrid Ablation Probe received FDA 510(k) clearance on 2025-12-18, under 510(k) number K253915.

Who is the listed applicant for MOVIVA® Hybrid Ablation Probe?

The FDA 510(k) record lists Erbe Elektromedizin GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOVIVA® Hybrid Ablation Probe?

The FDA product code for MOVIVA® Hybrid Ablation Probe is GEI.

列明Erbe Elektromedizin GmbH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。

K261806ERBECRYO 2 冷冻手术单元及附件 K253230ERBECRYO 2 冷冻手术单元及附件：ERBECRYO 2 冷冻手术单元；Erbe 弹性冷冻探头 K251108Erbe ESU 型号 VIO® 3n 及附件 K243120混合APC探头 K243451FiAPC plus探头 K242044FiAPC plus探头

查看所有 15 个设备 →

相关器械（代码：GEI）

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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