FDA 510(k)

CORE-SPORT

K号: K220081 · 2022-09-28

决定日期2022-09-28

产品代码OTJ

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决定实质等同

器械摘要

CORE-SPORT 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 2022-09-28 under 510(k) number K220081. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CORE-SPORT?

CORE-SPORT is a medical device that received FDA 510(k) clearance on 2022-09-28. The listed applicant is Incore Co., Ltd.. The 510(k) number is K220081.

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

CORE-SPORT received FDA 510(k) clearance on 2022-09-28, under 510(k) number K220081.

Who is the listed applicant for CORE-SPORT?

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-SPORT?

The FDA product code for CORE-SPORT is OTJ.

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）K221054CORE-INJECTOR K220846CORE-SNARE K213338CORE-CLIP K211148CORE-Trocar

官方来源

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