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FDA 510(k)

Unistik TinyTouch 无菌单次使用足跟切口安全注射针 - 早产儿和足月儿，Unistik Heelstik 无菌单次使用足跟切口安全注射针 - 微早产儿、早产儿、足月儿和幼儿

K号: K222168 · 2022-11-03

申请人Owen Mumford, Ltd.
决定日期2022-11-03
产品代码FMK
咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-11-03 under 510(k) number K222168. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler?

Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler is a medical device that received FDA 510(k) clearance on 2022-11-03. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K222168.

When did Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler receive FDA 510(k) clearance?

Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler received FDA 510(k) clearance on 2022-11-03, under 510(k) number K222168.

Who is the listed applicant for Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler?

The FDA 510(k) record lists Owen Mumford, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler?

The FDA product code for Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler is FMK.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明Owen Mumford, 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。

K223854Unistik® ShieldLock，Unistik VacuFlipK231124Unistik® 3 单次使用安全采血针：- 额外（21G）、标准（23G）、舒适（28G）、温柔（30G）K222303Unistik® ProK221613Freestyle Lancing Device II，Autolet，Autolet Lite，Unilet 刺针K222111Unistik Touch 单次使用安全采血针 - 16G、21G、23G、28G 和 30GK221126Unistik® 3，无菌一次性安全采血针；Unistik® 3 Value，无菌一次性安全采血针；Abbott SF无菌一次性安全采血针

查看所有 10 个设备 →

相关器械（代码：FMK）

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。

K262526安全采血针（XL）Tianjin Huahong Technology Co., Ltd.K261045Verifine 安全采血针Promisemed Hangzhou Meditech Co., Ltd.K260191安全型刀片（XXXVII）Tianjin Huahong Technology Co., Ltd.K253605安全足跟注射针Ningbo Medsun Medical Co., Ltd.K252490足跟棒安全刀片（HHZ-II，HHZ-III，HHZ-IV）Tianjin Huahong Technology Co., Ltd.K251694安全注射针Tianjin Huahong Technology Co., 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。

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