伤口基因NPWT系统
K号: K254019 · 2026-05-04
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决定日期2026-05-04
产品代码OMP
咨询委员会SU
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器械摘要
Wound Geni NPWT System is the device name listed in this FDA 510(k) record. The listed applicant is Bechtel Medical, Inc.. It received FDA 510(k) clearance on 2026-05-04 under 510(k) number K254019. 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 Wound Geni NPWT System?
Wound Geni NPWT System is a medical device that received FDA 510(k) clearance on 2026-05-04. The listed applicant is Bechtel Medical, Inc.. The 510(k) number is K254019.
When did Wound Geni NPWT System receive FDA 510(k) clearance?
Wound Geni NPWT System received FDA 510(k) clearance on 2026-05-04, under 510(k) number K254019.
Who is the listed applicant for Wound Geni NPWT System?
The FDA 510(k) record lists Bechtel Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Wound Geni NPWT System?
The FDA product code for Wound Geni NPWT System is OMP.
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：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 BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT 罐 500-毫升 (CPC-500)Cork MedicalK253429Genadyne 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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