CURASYS 2 (EMDN0003)
K号: K253199 · 2026-06-23
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器械摘要
CURASYS 2 (EMDN0003) is the device name listed in this FDA 510(k) record. The listed applicant is CG Bio Co., Ltd.. It received FDA 510(k) clearance on 2026-06-23 under 510(k) number K253199. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CURASYS 2 (EMDN0003)?
CURASYS 2 (EMDN0003) is a medical device that received FDA 510(k) clearance on 2026-06-23. The listed applicant is CG Bio Co., Ltd.. The 510(k) number is K253199.
When did CURASYS 2 (EMDN0003) receive FDA 510(k) clearance?
CURASYS 2 (EMDN0003) received FDA 510(k) clearance on 2026-06-23, under 510(k) number K253199.
Who is the listed applicant for CURASYS 2 (EMDN0003)?
The FDA 510(k) record lists CG Bio Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CURASYS 2 (EMDN0003)?
The FDA product code for CURASYS 2 (EMDN0003) is OMP.
相关临床试验
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列明CG Bio 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。
相关器械（代码：OMP）
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。
K261338RENASYS DYNAFLOW 套件（66807741）Smith & Nephew Medical, Ltd.K253263ConvaVAC™ 负压伤口治疗系统Convatec Limited, Gdc BuildingK260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 罐 500-毫升 (CPC-500)Cork MedicalK254019伤口基因NPWT系统Bechtel Medical, Inc.K253429Genadyne ASTRA NPWTGenadyne Biotechnologies, Inc.
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。
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