KGN — Wound Dressing With Animal-Derived Material(S) Class U
FDA Device Classification
Classification Details
- Product Code
- KGN
- Device Class
- Class U
- Regulation Number
- Submission Type
- Review Panel
- SU
- Medical Specialty
- Unknown
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K260218 | lacerta life sciences | LacertaMatrix | February 19, 2026 |
| K253140 | ovigenex | CollOvine Wound Powder | February 10, 2026 |
| K251323 | geistlich pharma | Device 104 Particulate | January 22, 2026 |
| K252673 | lacerta life science | LacertaMatrix | December 22, 2025 |
| K253339 | stimlabs | Theracor | December 22, 2025 |
| K250864 | medskin solutions dr. suwelack | MatriDerm pluS+ Bi-Layer | December 19, 2025 |
| K242100 | maxigen biotech | SurgiAid Collagen Wound Dressing (HA) | October 16, 2025 |
| K252001 | winner medical co | Collagen Wound Dressing | October 10, 2025 |
| K250397 | helios biomedical | Helios Dermal Scaffold | August 15, 2025 |
| K251845 | kerecis limited | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | July 16, 2025 |
| K250329 | geniphys | GeniPhys Collymer Self-Assembling Scaffold | June 25, 2025 |
| K242985 | ovigenex | CollOvine Wound Dressing | June 20, 2025 |
| K241904 | fesariustherapeutics | DermiSphere Dermal Template | January 6, 2025 |
| K243071 | collagen matrix | Bovine Dermis Collagen Dermal Matrix | December 19, 2024 |
| K242146 | smith and nephew medical limited | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | December 17, 2024 |
| K233378 | acro biomedical co | ABCcolla® Collagen ADM Scaffold | October 18, 2024 |
| K242828 | stimlabs | Corplex P/ Theracor P/ Allacor P | October 18, 2024 |
| K241080 | kerecis limited | Kerecis Parvus (50207) | August 21, 2024 |
| K241866 | convatec triad life sciences | InnovaMatrix®FD | July 26, 2024 |
| K241706 | acell | MicroMatrix® UBM Particulate | July 11, 2024 |