Hypodermic Needle-Pro EDGE Safety Device
K号: K211634 · 2021-08-26
广告
决定日期2021-08-26
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
Hypodermic Needle-Pro EDGE Safety Device is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2021-08-26 under 510(k) number K211634. 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 Hypodermic Needle-Pro EDGE Safety Device?
Hypodermic Needle-Pro EDGE Safety Device is a medical device that received FDA 510(k) clearance on 2021-08-26. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K211634.
When did Hypodermic Needle-Pro EDGE Safety Device receive FDA 510(k) clearance?
Hypodermic Needle-Pro EDGE Safety Device received FDA 510(k) clearance on 2021-08-26, under 510(k) number K211634.
Who is the listed applicant for Hypodermic Needle-Pro EDGE Safety Device?
The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Hypodermic Needle-Pro EDGE Safety Device?
The FDA product code for Hypodermic Needle-Pro EDGE Safety Device is FMI.
相关临床试验
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。
列明Smiths Medical Asd, Inc.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。
K232943Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space SyringeK210833Portex BLUxl 长型气管切开管，BLUxl 吸痰辅助长型气管切开管，BLUxl 长型气管切开管内芯K192375Intellifuse给药和Intellifuse血液给药套装K181699Level 1对流加热器K172800Portex® Lancet Point 脊髓穿刺针带NRFit®连接器，Portex® Pencil Point 脊髓穿刺针带NRFit®连接器K172823Portex NRFit 蛛网膜下腔穿刺针
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 BHDK261719Promisemed 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
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。
广告