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 |
|---|---|---|---|
| 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 |
| K253204 | Catalyze | BioTissue Holdings, Inc. | 2026-06-05 |
| 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 |
|---|---|---|---|
| 00810179632410 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632762 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632755 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632748 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632731 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632724 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632717 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632700 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632694 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632687 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632670 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632663 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632656 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632632 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632403 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632427 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632434 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632441 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632458 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632465 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632472 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632595 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632601 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632618 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632625 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 00810179632649 | OASIS | COOK BIOTECH INCORPORATED | 2026-07-31 |
| 09421908222515 | Myriad Meshed Soft Tissue Bioscaffold | AROA BIOSURGERY LIMITED | 2026-07-04 |
| 00366977333337 | ACM Surgical Collagen | Mpm Medical, LLC | 2022-12-07 |
| 04250569301780 | MatriDerm | MedSkin Solutions Dr. Suwelack AG | 2021-10-15 |
| 00841336100886 | Salvin Dental Specialties | SALVIN DENTAL SPECIALTIES, LLC | 2020-02-28 |