KGN — Wound Dressing With Animal-Derived Material(S) Class U
FDA product code KGN covers "Wound Dressing With Animal-Derived Material(S)", a Class U medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
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 |
|---|---|---|---|
| K260596 | ventris medical | Collagen Wound Powder | July 2, 2026 |
| K260669 | aroa biosurgery | Endoform Dermal Template | June 24, 2026 |
| K253521 | ecm therapeutics | ECMT-100 WMD | June 18, 2026 |
| K253204 | biotissue holdings | Catalyze | June 5, 2026 |
| K253974 | roosin medical co | Roosin Collagen Dressing | June 3, 2026 |
| K254034 | roosin medical co | Roosin Collagen Powder | June 3, 2026 |
| K261224 | medskin solutions dr. suwelack | MatriDerm | May 14, 2026 |
| K260532 | geistlich pharma | Derma-Gide | March 19, 2026 |
| 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 |