FDA 510(k)

SIRA™ RFA 电外科设备

K号: K232947 · 2023-12-12

决定日期2023-12-12

产品代码GEI

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决定实质等同

器械摘要

SIRA™ RFA Electrosurgical Device is the device name listed in this FDA 510(k) record. The listed applicant is Innoblative Designs, Inc.. It received FDA 510(k) clearance on 2023-12-12 under 510(k) number K232947. 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 SIRA™ RFA Electrosurgical Device?

SIRA™ RFA Electrosurgical Device is a medical device that received FDA 510(k) clearance on 2023-12-12. The listed applicant is Innoblative Designs, Inc.. The 510(k) number is K232947.

When did SIRA™ RFA Electrosurgical Device receive FDA 510(k) clearance?

SIRA™ RFA Electrosurgical Device received FDA 510(k) clearance on 2023-12-12, under 510(k) number K232947.

Who is the listed applicant for SIRA™ RFA Electrosurgical Device?

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

What is the FDA product code for SIRA™ RFA Electrosurgical Device?

The FDA product code for SIRA™ RFA Electrosurgical Device is GEI.

列明Innoblative Designs, 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。

K181071SIRA RFA 电外科设备

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。

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