FDA 510(k)

一次性止血夹（AF系列）

K号: K231633 · 2024-01-11

申请人Alton (Shanghai) Medical Instruments Co., Ltd.

决定日期2024-01-11

产品代码PKL

咨询委员会GU 请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。

决定实质等同

器械摘要

Disposable Hemoclip (AF series) is the device name listed in this FDA 510(k) record. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2024-01-11 under 510(k) number K231633. 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 Disposable Hemoclip (AF series)?

Disposable Hemoclip (AF series) is a medical device that received FDA 510(k) clearance on 2024-01-11. The listed applicant is Alton (Shanghai) Medical Instruments Co., Ltd.. The 510(k) number is K231633.

When did Disposable Hemoclip (AF series) receive FDA 510(k) clearance?

Disposable Hemoclip (AF series) received FDA 510(k) clearance on 2024-01-11, under 510(k) number K231633.

Who is the listed applicant for Disposable Hemoclip (AF series)?

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

What is the FDA product code for Disposable Hemoclip (AF series)?

The FDA product code for Disposable Hemoclip (AF series) is PKL.

列明Alton (Shanghai) Medical Instruments 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。

K243039输尿管支架（AF-D系列）K242635内窥镜远端附件（AF-D系列）K241679一次性细胞刷（AF系列）K241285一次性内镜阀门组件套件（AF系列）K230925一次性注射针 AF 系列

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

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