FDA 510(k)

HF 手术发生器 400KHZ

K号: K230194 · 2023-03-22

申请人Richard Wolf Medical Instruments Corporation

决定日期2023-03-22

产品代码GEI

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决定实质等同

器械摘要

HF Surgery Generator 400KHZ is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corporation. It received FDA 510(k) clearance on 2023-03-22 under 510(k) number K230194. 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 HF Surgery Generator 400KHZ?

HF Surgery Generator 400KHZ is a medical device that received FDA 510(k) clearance on 2023-03-22. The listed applicant is Richard Wolf Medical Instruments Corporation. The 510(k) number is K230194.

When did HF Surgery Generator 400KHZ receive FDA 510(k) clearance?

HF Surgery Generator 400KHZ received FDA 510(k) clearance on 2023-03-22, under 510(k) number K230194.

Who is the listed applicant for HF Surgery Generator 400KHZ?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HF Surgery Generator 400KHZ?

The FDA product code for HF Surgery Generator 400KHZ is GEI.

列明Richard Wolf Medical Instruments Corporation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。

K231291穿孔篮 K212808Logic Hd相机头绿色，系统绿色 K211332D相机控制器 K203226TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM K201897Sensor-Ureterorenoscope 9 FR WL 600 MM (短RIWO D-URS), 控制器适配器 5525 K200617Logic HD相机控制器，Logic HD Lite相机控制器，Logic 4K相机控制器，控制器5525适配器

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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。

K254196HARMONIC 1100 剪刀（HAR1120）；HARMONIC 1100 剪刀（HAR1136）Ethicon Endo-Surgery, LLC K261959Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，推钮开关（0703-046-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，推钮开关，大批量非无菌（0703-046-102）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，70mm刀片，旋转开关（0703-047-100）；Neptune® SafeAir® 10英尺烟雾排放笔，方形涂层，旋转开关，大批量非无菌（0703-047-102）Stryker Instruments K261070LigaSure™ RAS 马里兰州颚部血管封合/分割器，纳米涂层Covidien, LLC K254185Potenza PrimeJeisys Medical Incorporated K262364艾利安谜团射频设备Ellian Corp K253859Scarlet Pro（Scarlet Pro）VIOL Co., Ltd.

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