Collagen Wound Dressing
FDA 510(k) K231152 · Winner Medical Co., Ltd.
510(k) numberK231152
Submission
- Device name
- Collagen Wound Dressing
- Applicant
- Winner Medical Co., Ltd.
Shenzhen, CN - Received
- April 24, 2023
- Decision date
- October 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code KGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260652 | ColActive PlusKGN · Traditional | Covalon Technologies, Ltd. | 09/09/2026SE |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | Berkeley Advanced Biomaterials | 08/27/2026SE |
| K260596 | Collagen Wound PowderKGN · Traditional | Ventris Medical | 07/02/2026SE |
| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
| K253521 | ECMT-100 WMDKGN · Traditional | Ecm Therapeutics, Inc. | 06/18/2026SE |
| K253204 | CatalyzeKGN · Traditional | BioTissue Holdings, Inc. | 06/05/2026SE |
| K254034 | Roosin Collagen PowderKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K253974 | Roosin Collagen DressingKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K261224 | MatriDermKGN · Special | Medskin Solutions Dr. Suwelack AG | 05/14/2026SE |
| K260532 | Derma-GideKGN · Special | Geistlich Pharma AG | 03/19/2026SE |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K252001 | Collagen Wound DressingKGN · Traditional | 10/10/2025SE |
| K250082 | Procedure mask/Surgical mask/Face maskFXX · Traditional | 06/18/2025SE |
| K231057 | Antibacterial Gel Wound DressingFRO · Traditional | 12/01/2023SE |
| K231564 | Skin and Wound CleanserFRO · Traditional | 11/10/2023SE |
| K221311 | Antibacterial BandageFRO · Traditional | 06/21/2023SE |
| K223232 | Procedure mask/Surgical mask/Face maskFXX · Traditional | 03/06/2023SE |
| K221532 | PHMB Wound DressingFRO · Traditional | 01/30/2023SE |
| K221754 | Ag Foam Dressing Non-Adhesive (OTC); Ag Foam Dressing Adhesive (OTC); Silicone Ag Foam…FRO · Special | 01/17/2023SE |
| K221755 | Antimicrobial gauze sponge dressing; Antimicrobial super sponge dressing; Antimicrobial…FRO · Special | 01/13/2023SE |
| K221720 | Extra Silver Gelling Fiber DressingFRO · Traditional | 12/21/2022SE |
Questions and answers
When was Collagen Wound Dressing cleared by the FDA?
Collagen Wound Dressing (K231152) received a 510(k) decision of Substantially Equivalent on October 12, 2023, 171 days after the submission was received.
What is the product code of K231152?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.