FDA 510(k)

CORE-CLIP

K号: K213338 · 2022-06-23

决定日期2022-06-23

产品代码PKL

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决定实质等同

器械摘要

CORE-CLIP 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 2022-06-23 under 510(k) number K213338. The device is classified under product code PKL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CORE-CLIP?

CORE-CLIP is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Incore Co., Ltd.. The 510(k) number is K213338.

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

CORE-CLIP received FDA 510(k) clearance on 2022-06-23, under 510(k) number K213338.

Who is the listed applicant for CORE-CLIP?

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-CLIP?

The FDA product code for CORE-CLIP is PKL.

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 K220081CORE-SPORT K211148CORE-Trocar

相关器械（代码：PKL）

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。

K253481结肠FTRD套件（200.70）；诊断FTRD套件（200.76）；胃十二指肠FTRD套件（200.72）Ovesco Endoscopy AG K254069血液夹（511系列，543系列）Hangzhou AGS MedTech Co., Ltd.K260580单次使用可重装夹子应用器（HX-810LR，HX-810UR）；夹子（HX-610-090，HX-610-135）；长夹子（HX-610-090L，HX-610-135L）；短夹子（HX-610-090S，HX-610-135S）；超短夹子（HX-610-135XS）Olympus Medical Systems Corp.K252270HemoclipHangzhou AGS MedTech Co., Ltd.K253734Taurus 钳Taurus Endoscopy K251562OTSCneo 系统套装 (100.03n-14n, 100.27n-31n)Ovesco Endoscopy AG

官方来源

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