FDA 510(k)

一次性自动回缩安全注射器（带可拆卸针头）

K号: K222452 · 2022-11-23

申请人Shantou Wealy Medical Instrument Co.,Ltd

决定日期2022-11-23

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

Disposable Automatically Retractable Safety Syringes (with detachable needle) is the device name listed in this FDA 510(k) record. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. It received FDA 510(k) clearance on 2022-11-23 under 510(k) number K222452. 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 Disposable Automatically Retractable Safety Syringes (with detachable needle)?

Disposable Automatically Retractable Safety Syringes (with detachable needle) is a medical device that received FDA 510(k) clearance on 2022-11-23. The listed applicant is Shantou Wealy Medical Instrument Co.,Ltd. The 510(k) number is K222452.

When did Disposable Automatically Retractable Safety Syringes (with detachable needle) receive FDA 510(k) clearance?

Disposable Automatically Retractable Safety Syringes (with detachable needle) received FDA 510(k) clearance on 2022-11-23, under 510(k) number K222452.

Who is the listed applicant for Disposable Automatically Retractable Safety Syringes (with detachable needle)?

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

What is the FDA product code for Disposable Automatically Retractable Safety Syringes (with detachable needle)?

The FDA product code for Disposable Automatically Retractable Safety Syringes (with detachable needle) is MEG.

列明Shantou Wealy Medical Instrument 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。

K210216一次性自动回缩胰岛素安全注射器 K203613ENFit 可重复使用肠内注射器 K203410ENFit 一次性肠内注射器

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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