DermiSphere 皮肤模板
K号: K241904 · 2025-01-06
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器械摘要
DermiSphere Dermal Template is the device name listed in this FDA 510(k) record. The listed applicant is Fesariustherapeutics, Inc.. It received FDA 510(k) clearance on 2025-01-06 under 510(k) number K241904. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.
常见问题
What is the DermiSphere Dermal Template?
DermiSphere Dermal Template is a medical device that received FDA 510(k) clearance on 2025-01-06. The listed applicant is Fesariustherapeutics, Inc.. The 510(k) number is K241904.
When did DermiSphere Dermal Template receive FDA 510(k) clearance?
DermiSphere Dermal Template received FDA 510(k) clearance on 2025-01-06, under 510(k) number K241904.
Who is the listed applicant for DermiSphere Dermal Template?
The FDA 510(k) record lists Fesariustherapeutics, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DermiSphere Dermal Template?
The FDA product code for DermiSphere Dermal Template is KGN.
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：KGN）
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。
K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus 手术基质，1cc（CG-01AP）；Accelagen Plus 手术基质，3cc（CG-03AP）；Accelagen Plus 手术基质，5cc（CG-05AP）；Accelagen Plus 手术条带，125x25x2mm（CG-125X25AP）；Accelagen Plus 手术条带，250x25x2mm（CG-250X25AP）Berkeley Advanced BiomaterialsK260596胶原蛋白伤口粉Ventris MedicalK260669Endoform 皮肤模板Aroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, 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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