FDA 510(k)

SurGuard3安全皮下注射针

K号: K212095 · 2022-08-22

决定日期2022-08-22

产品代码FMI

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

SurGuard3 Safety Hypodermic Needle 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 2022-08-22 under 510(k) number K212095. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SurGuard3 Safety Hypodermic Needle?

SurGuard3 Safety Hypodermic Needle is a medical device that received FDA 510(k) clearance on 2022-08-22. The listed applicant is Terumo Europe N.V.. The 510(k) number is K212095.

When did SurGuard3 Safety Hypodermic Needle receive FDA 510(k) clearance?

SurGuard3 Safety Hypodermic Needle received FDA 510(k) clearance on 2022-08-22, under 510(k) number K212095.

Who is the listed applicant for SurGuard3 Safety Hypodermic Needle?

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 SurGuard3 Safety Hypodermic Needle?

The FDA product code for SurGuard3 Safety Hypodermic Needle is FMI.

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)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 K161606带固定针头的注射器 - 仅用于 GONAL-F 多剂量 600 I/U mL FSH

查看所有 7 个设备 →

相关器械（代码：FMI）

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。

K261266MOWANA™ 自动双联PENTAMASTER MEDIQ SDN BHD K261719Promisemed X 安全笔式针头Promisemed Hangzhou Meditech Co., Ltd.K262427注射针（普通型I类，安全型IIA，安全型IIB，安全型IIIA，安全型IIIB，安全型IV，安全型V，普通型VIA，普通型VIB，普通型VIC，安全型VII，普通型IB，安全型VIII，安全型IX，安全型X，普通型XI，安全型XII）Hh Global Technology, Inc.K260933安全无菌皮下注射针（NR-S1816R、NR-S1916R、NR-S1925R、NR-S1938R、NR-S2016R、NR-S2025R、NR-S2038R、NR-S2051R、NR-S2116R、NR-S2125R、NR-S2138R、NR-S2151R、NR-S2216R、NR-S2225R、NR-S2238R、NR-S2251R、NR-S2316R、NR-S2325R、NR-S2338R、NR-S2351R、NR-S2516R、NR-S2525R、NR-S2538R、NR-S2551R、NR-S2516T、NR-S2525T、NR-S2538T、NR-S2551T）Hangzhou Qiantang Longyue Biotechnology Co., Ltd.K261829Profoject™ 双重安全笔式针头CMT Health PTE., Ltd.K260739Profoject™ 注射针（型号A；型号B）CMT Health PTE., Ltd.

官方来源

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