# KGN · Wound Dressing With Animal-Derived Material(S)

_ ·  · Class U_

**Canonical URL:** https://fda.innolitics.com/productcode/KGN

## Overview

- **Product Code:** KGN
- **Device Name:** Wound Dressing With Animal-Derived Material(S)
- **Regulation:** 21 CFR N/A
- **Device Class:** U
- **Review Panel:** [](/submissions/)
- **Implant:** yes

## Recent Cleared Devices (20 of 187)

Showing 20 most recent of 187 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253204](/device/K253204.md) | Catalyze | BioTissue Holdings, Inc. | Jun 5, 2026 | SESE |
| [K254034](/device/K254034.md) | Roosin Collagen Powder | Roosin Medical Co., Ltd. | Jun 3, 2026 | SESE |
| [K253974](/device/K253974.md) | Roosin Collagen Dressing | Roosin Medical Co., Ltd. | Jun 3, 2026 | SESE |
| [K261224](/device/K261224.md) | MatriDerm | Medskin Solutions Dr. Suwelack AG | May 14, 2026 | SESE |
| [K260532](/device/K260532.md) | Derma-Gide | Geistlich Pharma AG | Mar 19, 2026 | SESE |
| [K260218](/device/K260218.md) | LacertaMatrix | Lacerta Life Sciences | Feb 19, 2026 | SESE |
| [K253140](/device/K253140.md) | CollOvine™ Wound Powder | Ovigenex, LLC | Feb 10, 2026 | SESE |
| [K251323](/device/K251323.md) | Device 104 Particulate | Geistlich Pharma AG | Jan 22, 2026 | SESE |
| [K253339](/device/K253339.md) | Theracor | Stimlabs, LLC | Dec 22, 2025 | SESE |
| [K252673](/device/K252673.md) | LacertaMatrix | Lacerta Life Science | Dec 22, 2025 | SESE |
| [K250864](/device/K250864.md) | MatriDerm pluS+ Bi-Layer | Medskin Solutions Dr. Suwelack AG | Dec 19, 2025 | SESE |
| [K242100](/device/K242100.md) | SurgiAid Collagen Wound Dressing  (HA) | Maxigen Biotech, Inc. | Oct 16, 2025 | SESE |
| [K252001](/device/K252001.md) | Collagen Wound Dressing | Winner Medical Co., Ltd. | Oct 10, 2025 | SESE |
| [K250397](/device/K250397.md) | Helios Dermal Scaffold | Helios Biomedical, Inc. | Aug 15, 2025 | SESE |
| [K251845](/device/K251845.md) | Marigen Wound Extra; Kerecis Silicone; Kerecis Parvus | Kerecis Limited | Jul 16, 2025 | SESE |
| [K250329](/device/K250329.md) | GeniPhys Collymer Self-Assembling Scaffold | Geniphys, Inc. | Jun 25, 2025 | SESE |
| [K242985](/device/K242985.md) | CollOvine™ Wound Dressing | Ovigenex, LLC | Jun 20, 2025 | SESE |
| [K241904](/device/K241904.md) | DermiSphere Dermal Template | Fesariustherapeutics, Inc. | Jan 6, 2025 | SESE |
| [K243071](/device/K243071.md) | Bovine Dermis Collagen Dermal Matrix | Collagen Matrix, Inc. | Dec 19, 2024 | SESE |
| [K242146](/device/K242146.md) | BIOBRANE Temporary Wound Dressing; BIOBRANE Glove | Smith & Nephew Medical Limited | Dec 17, 2024 | SESE |

## Top Applicants

- Acell, Inc. — 13 clearances
- Collagen Matrix, Inc. — 8 clearances
- Innocoll Pharmaceuticals — 6 clearances
- Geistlich Pharma AG — 5 clearances
- Integra Lifesciences Corp. — 5 clearances

---

**Source:** [https://fda.innolitics.com/productcode/KGN](https://fda.innolitics.com/productcode/KGN)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com