LUOFUCON® Collagen Particles (Collagen Wound Dressing)
FDA 510(k) K232796 · Huizhou Foryou Medical Devices Co., Ltd.
510(k) numberK232796
Submission
- Device name
- LUOFUCON® Collagen Particles (Collagen Wound Dressing)
- Applicant
- Huizhou Foryou Medical Devices Co., Ltd.
Huizhou, CN - Received
- September 12, 2023
- Decision date
- April 25, 2024
- 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 |
|---|---|---|
| K254256 | LUOFUCON® Wound MatrixQSZ · Traditional | 08/18/2026SE |
| K250642 | LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)FRO · Traditional | 11/19/2025SE |
| K240809 | LUOFUCON® Silver Collagen DressingFRO · Traditional | 12/16/2024SE |
| K242856 | LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+…FRO · Special | 11/13/2024SE |
| K240485 | LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver…FRO · Traditional | 10/07/2024SE |
| K223360 | LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam DressingFRO · Traditional | 03/27/2024SE |
| K221110 | LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber…FRO · Traditional | 01/04/2024SE |
| K223359 | LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam DressingFRO · Traditional | 12/21/2023SE |
| K213598 | LUOFUCON Collagen Wound DressingKGN · Traditional | 09/20/2022SE |
| K211123 | LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound GelFRO · Traditional | 04/22/2022SE |
Questions and answers
When was LUOFUCON® Collagen Particles (Collagen Wound Dressing) cleared by the FDA?
LUOFUCON® Collagen Particles (Collagen Wound Dressing) (K232796) received a 510(k) decision of Substantially Equivalent on April 25, 2024, 226 days after the submission was received.
What is the product code of K232796?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.