FDA 510(k)

无菌胆石取出球囊导管，取出球囊/短导线兼容

K号: K210229 · 2022-02-15

申请人Zhejiang Kangkang Medical-Devices Co., Ltd.

决定日期2022-02-15

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

Sterile Auto-Disable Syringes with/without Needle for Single Use is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. It received FDA 510(k) clearance on 2022-02-15 under 510(k) number K210229. 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 Sterile Auto-Disable Syringes with/without Needle for Single Use?

Sterile Auto-Disable Syringes with/without Needle for Single Use is a medical device that received FDA 510(k) clearance on 2022-02-15. The listed applicant is Zhejiang Kangkang Medical-Devices Co., Ltd.. The 510(k) number is K210229.

When did Sterile Auto-Disable Syringes with/without Needle for Single Use receive FDA 510(k) clearance?

Sterile Auto-Disable Syringes with/without Needle for Single Use received FDA 510(k) clearance on 2022-02-15, under 510(k) number K210229.

Who is the listed applicant for Sterile Auto-Disable Syringes with/without Needle for Single Use?

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

What is the FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use?

The FDA product code for Sterile Auto-Disable Syringes with/without Needle for Single Use is MEG.

列明Zhejiang Kangkang Medical-Devices 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。

K213535无菌一次性使用安全皮下注射针 K210232无菌一次性使用皮下注射针 K210227一次性无菌注射器（带/不带针）

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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