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FDA 510(k)

TRAUMAGEL® 2.0 止血凝胶

K号: K253609 · 2025-12-12

申请人Cresilon, Inc.
决定日期2025-12-12
产品代码QSY
决定实质等同

器械摘要

TRAUMAGEL® 2.0 Hemostatic Gel is the device name listed in this FDA 510(k) record. The listed applicant is Cresilon, Inc.. It received FDA 510(k) clearance on 2025-12-12 under 510(k) number K253609. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the TRAUMAGEL® 2.0 Hemostatic Gel?

TRAUMAGEL® 2.0 Hemostatic Gel is a medical device that received FDA 510(k) clearance on 2025-12-12. The listed applicant is Cresilon, Inc.. The 510(k) number is K253609.

When did TRAUMAGEL® 2.0 Hemostatic Gel receive FDA 510(k) clearance?

TRAUMAGEL® 2.0 Hemostatic Gel received FDA 510(k) clearance on 2025-12-12, under 510(k) number K253609.

Who is the listed applicant for TRAUMAGEL® 2.0 Hemostatic Gel?

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 TRAUMAGEL® 2.0 Hemostatic Gel?

The FDA product code for TRAUMAGEL® 2.0 Hemostatic Gel 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。

K240713TRAUMAGEL®K213652Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG)

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.K240713TRAUMAGEL®Cresilon, Inc.K240097多糖止血粉（HP-2，HP-3，HP-5）Ushare Medical, Inc.K232216Hemoblock_S（处方）；Hemoblock_S（OTC）Incore Co., Ltd.

官方来源

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