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FDA 510(k)

沸石止血纱布

K号: K211570 · 2022-02-10

申请人Hangzhou Zeo-Innov Life Technology Co., Ltd.
决定日期2022-02-10
产品代码QSY
决定实质等同

器械摘要

Zeolite Hemostatic Gauze is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Zeo-Innov Life Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-02-10 under 510(k) number K211570. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the Zeolite Hemostatic Gauze?

Zeolite Hemostatic Gauze is a medical device that received FDA 510(k) clearance on 2022-02-10. The listed applicant is Hangzhou Zeo-Innov Life Technology Co., Ltd.. The 510(k) number is K211570.

When did Zeolite Hemostatic Gauze receive FDA 510(k) clearance?

Zeolite Hemostatic Gauze received FDA 510(k) clearance on 2022-02-10, under 510(k) number K211570.

Who is the listed applicant for Zeolite Hemostatic Gauze?

The FDA 510(k) record lists Hangzhou Zeo-Innov Life Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zeolite Hemostatic Gauze?

The FDA product code for Zeolite Hemostatic Gauze is QSY.

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Hangzhou Zeo-Innov Life Technology Co., 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。

K223495沸石止血棉

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 LimitedK250319MFUSE (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.

官方来源

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