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FDA 510(k)

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)

K号: K213652 · 2023-06-28

申请人Cresilon, Inc.
决定日期2023-06-28
产品代码QSY
决定实质等同

器械摘要

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) is the device name listed in this FDA 510(k) record. The listed applicant is Cresilon, Inc.. It received FDA 510(k) clearance on 2023-06-28 under 510(k) number K213652. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)?

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) is a medical device that received FDA 510(k) clearance on 2023-06-28. The listed applicant is Cresilon, Inc.. The 510(k) number is K213652.

When did Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) receive FDA 510(k) clearance?

Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) received FDA 510(k) clearance on 2023-06-28, under 510(k) number K213652.

Who is the listed applicant for Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)?

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

What is the FDA product code for Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)?

The FDA product code for Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) 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Cresilon, 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。

K253609TRAUMAGEL® 2.0 止血凝胶K240713TRAUMAGEL®

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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