MFUSE (MS001)
K号: K250319 · 2025-12-15
广告
器械摘要
MFUSE (MS001) is the device name listed in this FDA 510(k) record. The listed applicant is Machina Medical, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) number K250319. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.
常见问题
What is the MFUSE (MS001)?
MFUSE (MS001) is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Machina Medical, Inc.. The 510(k) number is K250319.
When did MFUSE (MS001) receive FDA 510(k) clearance?
MFUSE (MS001) received FDA 510(k) clearance on 2025-12-15, under 510(k) number K250319.
Who is the listed applicant for MFUSE (MS001)?
The FDA 510(k) record lists Machina Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for MFUSE (MS001)?
The FDA product code for MFUSE (MS001) 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。
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 LimitedK253609TRAUMAGEL® 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.K232216Hemoblock_S(处方);Hemoblock_S(OTC)Incore Co., Ltd.
官方来源
在 FDA 数据库中查看 →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。
广告