FDA 510(k)

1毫升一次性无菌皮下注射器。带/不带针。鲁尔/鲁尔锁

K号: K210200 · 2021-05-14

申请人Set Medikal Sanayi VE Ticaret Anonim Sirketi

决定日期2021-05-14

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

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is the device name listed in this FDA 510(k) record. The listed applicant is Set Medikal Sanayi VE Ticaret Anonim Sirketi. It received FDA 510(k) clearance on 2021-05-14 under 510(k) number K210200. 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 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is a medical device that received FDA 510(k) clearance on 2021-05-14. The listed applicant is Set Medikal Sanayi VE Ticaret Anonim Sirketi. The 510(k) number is K210200.

When did 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock receive FDA 510(k) clearance?

1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock received FDA 510(k) clearance on 2021-05-14, under 510(k) number K210200.

Who is the listed applicant for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

The FDA 510(k) record lists Set Medikal Sanayi VE Ticaret Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock?

The FDA product code for 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock is FMF.

列明Set Medikal Sanayi VE Ticaret Anonim Sirketi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。

K201284一次性无菌皮下注射器，带/不带针，鲁尔/鲁尔锁，一次性无菌胰岛素注射器，带针，一次性无菌皮下针

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。