KGN
- Product code
- KGN
- Device name
- Wound Dressing With Animal-Derived Material(S)
- Device class
- Class U
- Medical specialty
- Unknown
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 41
- Summaries archived here
- 35 (direct download)
- 510(k) clearances (all years, FDA)
- 191 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (41)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K260711 | 2026-08-27 | Berkeley Advanced Biomaterials | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accela… | FDA |
| K260596 | 2026-07-02 | Ventris Medical | Collagen Wound Powder | |
| K260669 | 2026-06-24 | Aroa Biosurgery , Ltd. | Endoform Dermal Template | |
| K253521 | 2026-06-18 | Ecm Therapeutics, Inc. | ECMT-100 WMD | |
| K253204 | 2026-06-05 | BioTissue Holdings, Inc. | Catalyze | FDA |
| K254034 | 2026-06-03 | Roosin Medical Co., Ltd. | Roosin Collagen Powder | |
| K253974 | 2026-06-03 | Roosin Medical Co., Ltd. | Roosin Collagen Dressing | |
| K261224 | 2026-05-14 | Medskin Solutions Dr. Suwelack AG | MatriDerm | |
| K260532 | 2026-03-19 | Geistlich Pharma AG | Derma-Gide | |
| K260218 | 2026-02-19 | Lacerta Life Sciences | LacertaMatrix | |
| K253140 | 2026-02-10 | Ovigenex, LLC | CollOvine Wound Powder | FDA |
| K251323 | 2026-01-22 | Geistlich Pharma AG | Device 104 Particulate | FDA |
| K253339 | 2025-12-22 | Stimlabs, LLC | Theracor | |
| K252673 | 2025-12-22 | Lacerta Life Science | LacertaMatrix | |
| K250864 | 2025-12-19 | Medskin Solutions Dr. Suwelack AG | MatriDerm pluS+ Bi-Layer | |
| K242100 | 2025-10-16 | Maxigen Biotech, Inc. | SurgiAid Collagen Wound Dressing (HA) | |
| K252001 | 2025-10-10 | Winner Medical Co., Ltd. | Collagen Wound Dressing | |
| K250397 | 2025-08-15 | Helios Biomedical, Inc. | Helios Dermal Scaffold | |
| K251845 | 2025-07-16 | Kerecis Limited | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvu… | |
| K250329 | 2025-06-25 | Geniphys, Inc. | GeniPhys Collymer Self-Assembling Scaffold | |
| K242985 | 2025-06-20 | Ovigenex, LLC | CollOvine Wound Dressing | |
| K241904 | 2025-01-06 | Fesariustherapeutics, Inc. | DermiSphere Dermal Template | |
| K243071 | 2024-12-19 | Collagen Matrix, Inc. | Bovine Dermis Collagen Dermal Matrix | |
| K242146 | 2024-12-17 | Smith & Nephew Medical Limited | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | FDA |
| K233378 | 2024-10-18 | Acro Biomedical Co., Ltd. | ABCcolla® Collagen ADM Scaffold | |
| K242828 | 2024-10-18 | Stimlabs, LLC | Corplex P/ Theracor P/ Allacor P | |
| K241080 | 2024-08-21 | Kerecis Limited | Kerecis Parvus (50207) | |
| K241866 | 2024-07-26 | Convatec Triad Life Sciences, LLC | InnovaMatrix®FD | |
| K241724 | 2024-07-11 | Acell, Inc. | Cytal® Wound Matrix; Cytal® Burn Matrix | |
| K241706 | 2024-07-11 | Acell, Inc. | MicroMatrix® UBM Particulate | |
| K232796 | 2024-04-25 | Huizhou Foryou Medical Devices Co., Lt… | LUOFUCON® Collagen Particles (Collagen Wound Dressin… | |
| K232204 | 2024-04-19 | Fettech | ReyaGel (RG03 - MTP gel 3mL) | |
| K240753 | 2024-04-19 | Reprise Biomedical, Inc. | Miro3D Fibers Wound Matrix | |
| K240277 | 2024-03-01 | Reprise Biomedical, Inc. | MiroDry Wound Matrix | |
| K231325 | 2024-02-02 | Stimlabs, LLC | Corplex P / Theracor P / Allacor P | |
| K231614 | 2023-12-13 | Reprise Biomedical, Inc. | MiroTract Wound Matrix | FDA |
| K232758 | 2023-12-01 | Strukmyer Medical, LLC | Comatryx OTC | |
| K231937 | 2023-11-13 | Bionova Medical, Inc. | Foundation Dermal Regeneration Scaffold (DRS) Solo | |
| K231152 | 2023-10-12 | Winner Medical Co., Ltd. | Collagen Wound Dressing | |
| K223126 | 2023-10-11 | Maxigen Biotech, Inc. | SurgiAid® Collagen Wound Dressing | |
| K230980 | 2023-09-22 | Acell, Inc. | MicroMatrix® Flex |
Official FDA classification page: KGN
Classification and pathway per current FDA publications. Data from openFDA (CC0).