FDA 510(k)

刺针系统

K号: K232330 · 2024-01-04

决定日期2024-01-04

产品代码QRK

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决定实质等同

器械摘要

Lancing System is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-01-04 under 510(k) number K232330. The device is classified under product code QRK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lancing System?

Lancing System is a medical device that received FDA 510(k) clearance on 2024-01-04. The listed applicant is Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K232330.

When did Lancing System receive FDA 510(k) clearance?

Lancing System received FDA 510(k) clearance on 2024-01-04, under 510(k) number K232330.

Who is the listed applicant for Lancing System?

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

What is the FDA product code for Lancing System?

The FDA product code for Lancing System is QRK.

列明Ningbo Medsun Medical 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。

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相关器械（代码：QRK）

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。

K262631一次性血刺针（Soft Pro，Softsure，Softsure Pro，Softsense）SteriLance Medical (Suzhou), Inc.K261634一次性血刺针（软）SteriLance Medical (Suzhou), Inc.K250016droplet®个人采血针Htl-Strefa S.A K244031一次性血刺针（软Pro）；一次性血刺针（Softsure）；一次性血刺针（Softsure Pro）；一次性血刺针（Softsense）SteriLance Medical (Suzhou), Inc.K242622一次性无菌 lancetsNingbo Caremed Medical Products Co., Ltd.K241810MICROLET®NEXT 刺针Ascensia Diabetes Care U.S., Inc.

官方来源

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