设备104颗粒
K号: K251323 · 2026-01-22
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器械摘要
Device 104 Particulate is the device name listed in this FDA 510(k) record. The listed applicant is Geistlich Pharma AG. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K251323. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.
常见问题
What is the Device 104 Particulate?
Device 104 Particulate is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Geistlich Pharma AG. The 510(k) number is K251323.
When did Device 104 Particulate receive FDA 510(k) clearance?
Device 104 Particulate received FDA 510(k) clearance on 2026-01-22, under 510(k) number K251323.
Who is the listed applicant for Device 104 Particulate?
The FDA 510(k) record lists Geistlich Pharma AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Device 104 Particulate?
The FDA product code for Device 104 Particulate 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。
列明Geistlich Pharma AG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。
K260364设备300419条带K260532Derma-GideK252253Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide®K251062Geistlich Bio-Gide; Geistlich Bio-Gide® Shape; Geistlich Bio-Gide® Compressed; Geistlich Bio-Gide® Forte; Geistlich Bio-Gide® Perio; Geistlich Combi-Kit Collagen®; Geistlich Perio-System Combi PackK251556设备300423颗粒K251786Geistlich Bio-Oss®; Geistlich Bio-Oss Pen®
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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