FDA 510(k)

凝胶-e 弹性

K号: K180152 · 2018-06-22

决定日期2018-06-22

产品代码QSY

决定实质等同

器械摘要

gel-e Flex is the device name listed in this FDA 510(k) record. The listed applicant is Gel-E, Inc.. It received FDA 510(k) clearance on 2018-06-22 under 510(k) number K180152. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the gel-e Flex?

gel-e Flex is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Gel-E, Inc.. The 510(k) number is K180152.

When did gel-e Flex receive FDA 510(k) clearance?

gel-e Flex received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180152.

Who is the listed applicant for gel-e Flex?

The FDA 510(k) record lists Gel-E, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for gel-e Flex?

The FDA product code for gel-e Flex is QSY.

列明Gel-E, 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。

K192667凝胶-e Flex+凝胶OTC K182811凝胶-e Flex+

相关器械（代码：QSY）

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。

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm直径（FG100300）；Ganymede 5cm x 5cm（FG100400）；Ganymede 10cm x 10cm（FG100500）；Ganymede 15cm x 15cm（FG100600）；Ganymede 20cm x 30cm（FG100700）；Ganymede 25cm x 25cm（FG100800）；Ganymede 30cm x 30cm（FG100900）；Ganymede 40cm x 40cm （FG100999）；Ganymede 7.5cm x 120cm（FG100100）；Ganymede-X 2cm直径（FG100301）；Ganymede-X 5cm x 5cm（FG100401）；Ganymede-X 10cm x 10cm（FG100501）；Ganymede-X 15cm x 15cm（FG100601）；Ganymede-X 20cm x 30cm （FG100701）；Ganymede-X 25cmSpeciality Fibres and Materials Limited K250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 止血凝胶Cresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097多糖止血粉（HP-2，HP-3，HP-5）Ushare Medical, Inc.

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