KGN
- 产品代码
- KGN
- 器械名称
- Wound Dressing With Animal-Derived Material(S)
- 管理类别
- 第 U 类（Unclassified）
- FDA 专业组
- Unknown
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 属植入器械
- 该代码近三年的 510(k)
- 191 件
该代码近三年的 510(k)（41 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K260711 | 2026-08-27 | Berkeley Advanced Biomaterials | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accela 摘要 |
| K260596 | 2026-07-02 | Ventris Medical | Collagen Wound Powder 摘要 |
| K260669 | 2026-06-24 | Aroa Biosurgery , Ltd. | Endoform Dermal Template 摘要 |
| K253521 | 2026-06-18 | Ecm Therapeutics, Inc. | ECMT-100 WMD 摘要 |
| K253204 | 2026-06-05 | BioTissue Holdings, Inc. | Catalyze 摘要 |
| K254034 | 2026-06-03 | Roosin Medical Co., Ltd. | Roosin Collagen Powder 摘要 |
| K253974 | 2026-06-03 | Roosin Medical Co., Ltd. | Roosin Collagen Dressing 摘要 |
| K261224 | 2026-05-14 | Medskin Solutions Dr. Suwelack AG | MatriDerm 摘要 |
| K260532 | 2026-03-19 | Geistlich Pharma AG | Derma-Gide 摘要 |
| K260218 | 2026-02-19 | Lacerta Life Sciences | LacertaMatrix 摘要 |
| K253140 | 2026-02-10 | Ovigenex, LLC | CollOvine Wound Powder 摘要 |
| K251323 | 2026-01-22 | Geistlich Pharma AG | Device 104 Particulate 摘要 |
| K253339 | 2025-12-22 | Stimlabs, LLC | Theracor 摘要 |
| K252673 | 2025-12-22 | Lacerta Life Science | LacertaMatrix 摘要 |
| K250864 | 2025-12-19 | Medskin Solutions Dr. Suwelack AG | MatriDerm pluS+ Bi-Layer 摘要 |
| K242100 | 2025-10-16 | Maxigen Biotech, Inc. | SurgiAid Collagen Wound Dressing (HA) 摘要 |
| K252001 | 2025-10-10 | Winner Medical Co., Ltd. | Collagen Wound Dressing 摘要 |
| K250397 | 2025-08-15 | Helios Biomedical, Inc. | Helios Dermal Scaffold 摘要 |
| K251845 | 2025-07-16 | Kerecis Limited | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvu 摘要 |
| K250329 | 2025-06-25 | Geniphys, Inc. | GeniPhys Collymer Self-Assembling Scaffold 摘要 |
| K242985 | 2025-06-20 | Ovigenex, LLC | CollOvine Wound Dressing 摘要 |
| K241904 | 2025-01-06 | Fesariustherapeutics, Inc. | DermiSphere Dermal Template 摘要 |
| K243071 | 2024-12-19 | Collagen Matrix, Inc. | Bovine Dermis Collagen Dermal Matrix 摘要 |
| K242146 | 2024-12-17 | Smith & Nephew Medical Limited | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove 摘要 |
| K233378 | 2024-10-18 | Acro Biomedical Co., Ltd. | ABCcolla® Collagen ADM Scaffold 摘要 |
| K242828 | 2024-10-18 | Stimlabs, LLC | Corplex P/ Theracor P/ Allacor P 摘要 |
| K241080 | 2024-08-21 | Kerecis Limited | Kerecis Parvus (50207) 摘要 |
| K241866 | 2024-07-26 | Convatec Triad Life Sciences, LLC | InnovaMatrix®FD 摘要 |
| K241724 | 2024-07-11 | Acell, Inc. | Cytal® Wound Matrix; Cytal® Burn Matrix 摘要 |
| K241706 | 2024-07-11 | Acell, Inc. | MicroMatrix® UBM Particulate 摘要 |
| K232796 | 2024-04-25 | Huizhou Foryou Medical Devices Co., Lt | LUOFUCON® Collagen Particles (Collagen Wound Dressin 摘要 |
| K232204 | 2024-04-19 | Fettech | ReyaGel (RG03 - MTP gel 3mL) 摘要 |
| K240753 | 2024-04-19 | Reprise Biomedical, Inc. | Miro3D Fibers Wound Matrix 摘要 |
| K240277 | 2024-03-01 | Reprise Biomedical, Inc. | MiroDry Wound Matrix 摘要 |
| K231325 | 2024-02-02 | Stimlabs, LLC | Corplex P / Theracor P / Allacor P 摘要 |
| K231614 | 2023-12-13 | Reprise Biomedical, Inc. | MiroTract Wound Matrix 摘要 |
| K232758 | 2023-12-01 | Strukmyer Medical, LLC | Comatryx OTC 摘要 |
| K231937 | 2023-11-13 | Bionova Medical, Inc. | Foundation Dermal Regeneration Scaffold (DRS) Solo 摘要 |
| K231152 | 2023-10-12 | Winner Medical Co., Ltd. | Collagen Wound Dressing 摘要 |
| K223126 | 2023-10-11 | Maxigen Biotech, Inc. | SurgiAid® Collagen Wound Dressing 摘要 |
| K230980 | 2023-09-22 | Acell, Inc. | MicroMatrix® Flex 摘要 |
FDA 官方分类页： KGN
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。