FDA 510(k)

CORE-INJECTOR

K号: K221054 · 2022-12-21

决定日期2022-12-21

产品代码FBK

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决定实质等同

器械摘要

CORE-INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Incore Co., Ltd.. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K221054. The device is classified under product code FBK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CORE-INJECTOR?

CORE-INJECTOR is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Incore Co., Ltd.. The 510(k) number is K221054.

When did CORE-INJECTOR receive FDA 510(k) clearance?

CORE-INJECTOR received FDA 510(k) clearance on 2022-12-21, under 510(k) number K221054.

Who is the listed applicant for CORE-INJECTOR?

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

What is the FDA product code for CORE-INJECTOR?

The FDA product code for CORE-INJECTOR is FBK.

列明Incore 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。

K232216Hemoblock_S（处方）；Hemoblock_S（OTC）K220846CORE-SNARE K220081CORE-SPORT K213338CORE-CLIP K211148CORE-Trocar

相关器械（代码：FBK）

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。

官方来源

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