FDA 510(k)

Unistik Touch 单次使用安全采血针 - 16G、21G、23G、28G 和 30G

K号: K222111 · 2022-09-07

决定日期2022-09-07

产品代码FMK

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决定实质等同

器械摘要

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G 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 2022-09-07 under 510(k) number K222111. 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 Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G is a medical device that received FDA 510(k) clearance on 2022-09-07. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K222111.

When did Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G receive FDA 510(k) clearance?

Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G received FDA 510(k) clearance on 2022-09-07, under 510(k) number K222111.

Who is the listed applicant for Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?

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 Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?

The FDA product code for Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G is FMK.

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 VacuFlip K231124Unistik® 3 单次使用安全采血针：- 额外（21G）、标准（23G）、舒适（28G）、温柔（30G）K222168Unistik 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 K222303Unistik® Pro K221613Freestyle Lancing Device II，Autolet，Autolet Lite，Unilet 刺针 K221126Unistik® 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 →

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。