FDA 510(k)

OptaBlate RF 发生器，OptaBlate 探头，OptaBlate 微注射注射装置

K号: K221074 · 2022-09-16

决定日期2022-09-16

产品代码GEI

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决定实质等同

器械摘要

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corporation. It received FDA 510(k) clearance on 2022-09-16 under 510(k) number K221074. 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 OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is a medical device that received FDA 510(k) clearance on 2022-09-16. The listed applicant is Stryker Corporation. The 510(k) number is K221074.

When did OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device receive FDA 510(k) clearance?

OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device received FDA 510(k) clearance on 2022-09-16, under 510(k) number K221074.

Who is the listed applicant for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

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

What is the FDA product code for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device?

The FDA product code for OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device is GEI.

列明Stryker 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。

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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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