FDA 510(k)

一次性无菌皮下注射器（20ml，30ml，50ml，60ml）

K号: K252279 · 2026-04-17

决定日期2026-04-17

产品代码FMF

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 Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is the device name listed in this FDA 510(k) record. The listed applicant is Chirana T.Injecta,A.S.. It received FDA 510(k) clearance on 2026-04-17 under 510(k) number K252279. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is a medical device that received FDA 510(k) clearance on 2026-04-17. The listed applicant is Chirana T.Injecta,A.S.. The 510(k) number is K252279.

When did Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) receive FDA 510(k) clearance?

Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) received FDA 510(k) clearance on 2026-04-17, under 510(k) number K252279.

Who is the listed applicant for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

The FDA 510(k) record lists Chirana T.Injecta,A.S. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)?

The FDA product code for Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) is FMF.

列明Chirana T.Injecta,A.S.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。

K252483肠内注射器（20ml，60ml）

相关器械（代码：FMF）

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。

K262581GraftGun® 全能移植物输送系统（GDS®）SurGenTec, LLC K252184SOL-M可更换针盘式卢埃尔锁注射器Sol-Millennium Medical, Inc.K253747一次性笔式注射器（KXYC-03C02，KXYC-03A03）Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ 安全胰岛素注射器embecta Medical II, LLC K253110Sol-Glide安全针；带注射器的Sol-Glide安全针。Sol-Millennium Medical, Inc.K260514Profoject™ 安全针；Profoject™ 带安全针的注射器；Profoject™ 低死腔注射器带安全针CMT Health PTE., Ltd.

官方来源

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