FDA 510(k)

胰岛素注射器，带安全可回缩的胰岛素注射器

K号: K202570 · 2021-07-02

申请人Jiangsu Micsafe Medical Technology Co., Ltd.

决定日期2021-07-02

产品代码MEG

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

Insulin Syringe, Insulin Syringe with Safety Retractable is the device name listed in this FDA 510(k) record. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K202570. The device is classified under product code MEG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Insulin Syringe, Insulin Syringe with Safety Retractable?

Insulin Syringe, Insulin Syringe with Safety Retractable is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Jiangsu Micsafe Medical Technology Co., Ltd.. The 510(k) number is K202570.

When did Insulin Syringe, Insulin Syringe with Safety Retractable receive FDA 510(k) clearance?

Insulin Syringe, Insulin Syringe with Safety Retractable received FDA 510(k) clearance on 2021-07-02, under 510(k) number K202570.

Who is the listed applicant for Insulin Syringe, Insulin Syringe with Safety Retractable?

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

What is the FDA product code for Insulin Syringe, Insulin Syringe with Safety Retractable?

The FDA product code for Insulin Syringe, Insulin Syringe with Safety Retractable is MEG.

列明Jiangsu Micsafe Medical Technology 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。

K212019一次性使用血液采集针及带针座的血液采集针，一次性使用安全血液采集针及带针座的安全血液采集针，一次性使用血液采集套装及带针座的安全血液采集套装，一次性使用安全血液采集套装及带针座的血液采集套装 K202205Surgical Face Mask K183665安全注射针，无菌注射器，带安全注射针的无菌注射器，带针的无菌注射器，一次性皮下注射针 K181426口腔/肠内注射器（10 mL至60 mL）和低剂量尖端口腔/肠内注射器（1 mL至5 mL）

相关器械（代码：MEG）

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。

K252098PA3X可拆卸安全套筒注射器（带针）（SC-23ED / SD-23ED）Methyl Co., Ltd.K250847蒸汽盾Vault Paragon Group, Inc.K230287SaviSafe 安全设备Suzhou Savicred Biotechnology Co., Ltd.K231165Shina 注射器; Shina 安全注射器Shina Med Corporation K231907Medline 安全胰岛素和TB注射器Medline Industries, LP K223376Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110); Monoject Magellan Insulin Safety Syringe 0.5mL, 31G x 6mm (8881893150); Monoject Magellan Insulin Safety Syringe 0.3mL, 31G x 6mm (8881893130)Cardinal Health200, LLC

官方来源

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