FDA 510(k)

CURIS II射频发生器（REF 360100-05）

K号: K251813 · 2026-02-11

决定日期2026-02-11

产品代码GEI

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决定实质等同

器械摘要

CURIS II RF Generator (REF 360100-05) is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Medizintechnik GmbH. It received FDA 510(k) clearance on 2026-02-11 under 510(k) number K251813. 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 CURIS II RF Generator (REF 360100-05)?

CURIS II RF Generator (REF 360100-05) is a medical device that received FDA 510(k) clearance on 2026-02-11. The listed applicant is Sutter Medizintechnik GmbH. The 510(k) number is K251813.

When did CURIS II RF Generator (REF 360100-05) receive FDA 510(k) clearance?

CURIS II RF Generator (REF 360100-05) received FDA 510(k) clearance on 2026-02-11, under 510(k) number K251813.

Who is the listed applicant for CURIS II RF Generator (REF 360100-05)?

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

What is the FDA product code for CURIS II RF Generator (REF 360100-05)?

The FDA product code for CURIS II RF Generator (REF 360100-05) is GEI.

列明Sutter Medizintechnik 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。

K233425FlexTip 双极电极单次使用（AR-S9805-0028），FlexTip 双极电极单次使用（AR-S9805-0035）K193587Sutter Swyng防粘双极镊子，一次性使用 K192128Sutter Arrowtip单极电极 K191732Sutter RaVoR双极电极 K171869Sutter CURIS射频发生器

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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