Fibrillar Collagen Wound Dressing
FDA 510(k) K120250 · Collafirm, LLC
510(k) numberK120250
Submission
- Device name
- Fibrillar Collagen Wound Dressing
- Applicant
- Collafirm, LLC
Monmouth Jct, NJ, US - Received
- January 27, 2012
- Decision date
- April 21, 2013
- 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
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|---|---|---|---|
| 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 |
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| K141721 | Bovine Pericardium PatchFTM · Traditional | 12/22/2014SE |
Questions and answers
When was Fibrillar Collagen Wound Dressing cleared by the FDA?
Fibrillar Collagen Wound Dressing (K120250) received a 510(k) decision of Substantially Equivalent on April 21, 2013, 450 days after the submission was received.
What is the product code of K120250?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.