FDA 510(k)

带安全针的一次性无菌皮下注射器

K号: K221073 · 2022-10-04

申请人Sichuan Prius Biotechnology Co., Ltd.

决定日期2022-10-04

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 Hypodermic Syringes for Single Use with Safety Needles is the device name listed in this FDA 510(k) record. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2022-10-04 under 510(k) number K221073. 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 Hypodermic Syringes for Single Use with Safety Needles?

Sterile Hypodermic Syringes for Single Use with Safety Needles is a medical device that received FDA 510(k) clearance on 2022-10-04. The listed applicant is Sichuan Prius Biotechnology Co., Ltd.. The 510(k) number is K221073.

When did Sterile Hypodermic Syringes for Single Use with Safety Needles receive FDA 510(k) clearance?

Sterile Hypodermic Syringes for Single Use with Safety Needles received FDA 510(k) clearance on 2022-10-04, under 510(k) number K221073.

Who is the listed applicant for Sterile Hypodermic Syringes for Single Use with Safety Needles?

The FDA 510(k) record lists Sichuan Prius Biotechnology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Syringes for Single Use with Safety Needles?

The FDA product code for Sterile Hypodermic Syringes for Single Use with Safety Needles is MEG.

列明Sichuan Prius Biotechnology 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。

K221078Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use K221069带针一次性输液器 K221075一次性输液器 K221080无菌一次性使用安全皮下注射针 K221066无菌一次性使用皮下注射针 K221068带针的一次性无菌皮下注射器

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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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