FDA 510(k)

COOLIEF 冷射频套件

K号: K163236 · 2016-12-16

决定日期2016-12-16

产品代码GXI

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决定实质等同

器械摘要

COOLIEF Cooled Radiofrequency Kit is the device name listed in this FDA 510(k) record. The listed applicant is Halyard Health, Inc.. It received FDA 510(k) clearance on 2016-12-16 under 510(k) number K163236. The device is classified under product code GXI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the COOLIEF Cooled Radiofrequency Kit?

COOLIEF Cooled Radiofrequency Kit is a medical device that received FDA 510(k) clearance on 2016-12-16. The listed applicant is Halyard Health, Inc.. The 510(k) number is K163236.

When did COOLIEF Cooled Radiofrequency Kit receive FDA 510(k) clearance?

COOLIEF Cooled Radiofrequency Kit received FDA 510(k) clearance on 2016-12-16, under 510(k) number K163236.

Who is the listed applicant for COOLIEF Cooled Radiofrequency Kit?

The FDA 510(k) record lists Halyard Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOLIEF Cooled Radiofrequency Kit?

The FDA product code for COOLIEF Cooled Radiofrequency Kit is GXI.

列明Halyard Health, Inc.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。

K173955Mic-Key* SF Over-the-Wire Stoma 测量设备 K162930Aero Chrome* Select 透气性能手术服 K163461Coolief*冷却射频探头 K153255Aero Chrome* 透气性能手术服

相关器械（代码：GXI）

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。

K253907一次性射频消融电极ABBOTT MEDICAL K251802STAR RF Ablation SystemMerit Medical Systems, Inc.K251243OneRF 三叉神经射频探针Neuroone Medical Technologies Corp.K242841一次性射频电极（RFDE-5/RFDE-10/RFDE-15/RFDE-20）ABBOTT MEDICAL K250213OptaBlate BVN 骨内神经消融系统（10mm探头单套件）；OptaBlate BVN 骨内神经消融系统（10mm探头双套件）Stryker Instruments K241367使用多叉电极与传统电极进行腰椎椎间盘突出症射频消融的比较Shanghai Samedical & Plastic Instruments Co., Ltd.

官方来源

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