Product code KGN
- Device name
- Wound Dressing With Animal-Derived Material(S)
- Medical specialty
- Unknown
- Device class
- U
- Review panel
- SU
- Implant
- Y
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (... | Berkeley Advanced Biomaterials | 2026-08-27 |
| K260596 | Collagen Wound Powder | Ventris Medical | 2026-07-02 |
| K260669 | Endoform Dermal Template | Aroa Biosurgery , Ltd. | 2026-06-24 |
| K253521 | ECMT-100 WMD | Ecm Therapeutics, Inc. | 2026-06-18 |
| K253974 | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | 2026-06-03 |
| K254034 | Roosin Collagen Powder | Roosin Medical Co., Ltd. | 2026-06-03 |
| K261224 | MatriDerm | Medskin Solutions Dr. Suwelack AG | 2026-05-14 |
| K260532 | Derma-Gide | Geistlich Pharma AG | 2026-03-19 |
| K260218 | LacertaMatrix | Lacerta Life Sciences | 2026-02-19 |
| K253140 | CollOvine™ Wound Powder | Ovigenex, LLC | 2026-02-10 |
| K251323 | Device 104 Particulate | Geistlich Pharma AG | 2026-01-22 |
| K252673 | LacertaMatrix | Lacerta Life Science | 2025-12-22 |
| K253339 | Theracor | Stimlabs, LLC | 2025-12-22 |
| K250864 | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | 2025-12-19 |
| K242100 | SurgiAid Collagen Wound Dressing (HA) | Maxigen Biotech, Inc. | 2025-10-16 |
| K252001 | Collagen Wound Dressing | Winner Medical Co., Ltd. | 2025-10-10 |
| K250397 | Helios Dermal Scaffold | Helios Biomedical, Inc. | 2025-08-15 |
| K251845 | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | 2025-07-16 |
| K250329 | GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. | 2025-06-25 |
| K242985 | CollOvine™ Wound Dressing | Ovigenex, LLC | 2025-06-20 |
| K241904 | DermiSphere Dermal Template | Fesariustherapeutics, Inc. | 2025-01-06 |
| K243071 | Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. | 2024-12-19 |
| K242146 | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Smith & Nephew Medical Limited | 2024-12-17 |
| K233378 | ABCcolla® Collagen ADM Scaffold | Acro Biomedical Co., Ltd. | 2024-10-18 |
| K242828 | Corplex P/ Theracor P/ Allacor P | Stimlabs, LLC | 2024-10-18 |
| K241080 | Kerecis Parvus (50207) | Kerecis Limited | 2024-08-21 |
| K241866 | InnovaMatrix®FD | Convatec Triad Life Sciences, LLC | 2024-07-26 |
| K241706 | MicroMatrix® UBM Particulate | Acell, Inc. | 2024-07-11 |
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | Acell, Inc. | 2024-07-11 |
| K232796 | LUOFUCON® Collagen Particles (Collagen Wound Dressing) | Huizhou Foryou Medical Devices Co., Ltd. | 2024-04-25 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00841277111262 | Novera Renew | Harps USA, Inc. | 2026-08-26 |
| 00850086458062 | MaxioCel Chitosan Wound Dressing | Advamedica Inc. | 2026-08-21 |
| 00860012016679 | MaxioCel Chitosan Wound Dressing | Advamedica Inc. | 2026-08-21 |
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| 09421906017281 | Endoform™ Natural Restorative Bioscaffold | AROA BIOSURGERY LIMITED | 2021-08-20 |