FDA 510(k)

无菌一次性使用注射器及针头

K号: K163161 · 2017-03-20

申请人Jiangxi Hongda Medical Equipment Group , Ltd.

决定日期2017-03-20

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 Single-use Syringe with Needle is the device name listed in this FDA 510(k) record. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. It received FDA 510(k) clearance on 2017-03-20 under 510(k) number K163161. 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 Single-use Syringe with Needle?

Sterile Single-use Syringe with Needle is a medical device that received FDA 510(k) clearance on 2017-03-20. The listed applicant is Jiangxi Hongda Medical Equipment Group , Ltd.. The 510(k) number is K163161.

When did Sterile Single-use Syringe with Needle receive FDA 510(k) clearance?

Sterile Single-use Syringe with Needle received FDA 510(k) clearance on 2017-03-20, under 510(k) number K163161.

Who is the listed applicant for Sterile Single-use Syringe with Needle?

The FDA 510(k) record lists Jiangxi Hongda Medical Equipment Group , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sterile Single-use Syringe with Needle?

The FDA product code for Sterile Single-use Syringe with Needle is FMF.

列明Jiangxi Hongda Medical Equipment Group , 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。

K211753无菌安全注射器 K210578医用乳胶检查手套（免洗手，蓝色）K210821医用PVC检查手套 K163160无菌一次性使用输液器 K163162无菌一次性使用安全注射器

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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