FDA 510(k)

带流体泵系统的一次性电外科刀

K号: K211172 · 2021-12-17

决定日期2021-12-17

产品代码GEI

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决定实质等同

器械摘要

Single Use Electrosurgical Knife with Fluid Pump System is the device name listed in this FDA 510(k) record. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. It received FDA 510(k) clearance on 2021-12-17 under 510(k) number K211172. 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 Single Use Electrosurgical Knife with Fluid Pump System?

Single Use Electrosurgical Knife with Fluid Pump System is a medical device that received FDA 510(k) clearance on 2021-12-17. The listed applicant is Micro-Tech (Nanjing) Co., Ltd.. The 510(k) number is K211172.

When did Single Use Electrosurgical Knife with Fluid Pump System receive FDA 510(k) clearance?

Single Use Electrosurgical Knife with Fluid Pump System received FDA 510(k) clearance on 2021-12-17, under 510(k) number K211172.

Who is the listed applicant for Single Use Electrosurgical Knife with Fluid Pump System?

The FDA 510(k) record lists Micro-Tech (Nanjing) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Single Use Electrosurgical Knife with Fluid Pump System?

The FDA product code for Single Use Electrosurgical Knife with Fluid Pump System is GEI.

列明Micro-Tech (Nanjing) 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。

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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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