FDA 510(k)

带固定针头的注射器 - 仅用于 GONAL-F 多剂量 600 I/U mL FSH

K号: K161606 · 2017-02-10

决定日期2017-02-10

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

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Europe N.V.. It received FDA 510(k) clearance on 2017-02-10 under 510(k) number K161606. 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 Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is a medical device that received FDA 510(k) clearance on 2017-02-10. The listed applicant is Terumo Europe N.V.. The 510(k) number is K161606.

When did Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH receive FDA 510(k) clearance?

Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH received FDA 510(k) clearance on 2017-02-10, under 510(k) number K161606.

Who is the listed applicant for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

The FDA 510(k) record lists Terumo Europe N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH?

The FDA product code for Syringe with fixed needle - For use only with GONAL-F Multi-Dose 600 I/U mL FSH is FMF.

列明Terumo Europe N.V.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。

K251447K-Pack Embrace Active 安全针（KNAS-2516RB，KNAS-2525RB）K24330927G x 1/2 TW K-Pack Surshield针头（KN-S2713RBT）K243581K-Pack Enhance 针（KH-2713RBBTC和KH-2913RBBTC）K230951Terumo 注射过滤器针 (NF-3013RBKE05M)K212095SurGuard3安全皮下注射针 K192057K-Pack II 针 - 27G x 1/2" 超薄壁，K-Pack II 针 - 27G x 1/2" 超薄壁，K-Pack II 针 - 30G x 1/2" 超薄壁，K-Pack II 针 - 30G x 1/2" 超薄壁

查看所有 7 个设备 →

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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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。