FDA 510(k)

AB1 电外科器械，Creo 电外科系统

K号: K223138 · 2023-06-26

决定日期2023-06-26

产品代码NEY

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决定实质等同

器械摘要

AB1 Electrosurgical Instrument, Creo Electrosurgical System is the device name listed in this FDA 510(k) record. The listed applicant is Creo Medical, Ltd.. It received FDA 510(k) clearance on 2023-06-26 under 510(k) number K223138. The device is classified under product code NEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AB1 Electrosurgical Instrument, Creo Electrosurgical System?

AB1 Electrosurgical Instrument, Creo Electrosurgical System is a medical device that received FDA 510(k) clearance on 2023-06-26. The listed applicant is Creo Medical, Ltd.. The 510(k) number is K223138.

When did AB1 Electrosurgical Instrument, Creo Electrosurgical System receive FDA 510(k) clearance?

AB1 Electrosurgical Instrument, Creo Electrosurgical System received FDA 510(k) clearance on 2023-06-26, under 510(k) number K223138.

Who is the listed applicant for AB1 Electrosurgical Instrument, Creo Electrosurgical System?

The FDA 510(k) record lists Creo Medical, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AB1 Electrosurgical Instrument, Creo Electrosurgical System?

The FDA product code for AB1 Electrosurgical Instrument, Creo Electrosurgical System is NEY.

列明Creo Medical, 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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官方来源

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