Fibrillar Collagen Wound Dressing
FDA 510(k) K213341 · Collagen Matrix, Inc.
510(k) numberK213341
Submission
- Device name
- Fibrillar Collagen Wound Dressing
- Applicant
- Collagen Matrix, Inc.
Oakland, NJ, US - Received
- October 7, 2021
- Decision date
- May 31, 2022
- 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
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| 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 |
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| K221735 | Mineral Collagen Composite Bioactive MoldableMQV · Traditional | 12/20/2022SE |
| K202183 | Porcine Mineral Collagen CompositeNPM · Traditional | 04/02/2021SE |
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Questions and answers
When was Fibrillar Collagen Wound Dressing cleared by the FDA?
Fibrillar Collagen Wound Dressing (K213341) received a 510(k) decision of Substantially Equivalent on May 31, 2022, 236 days after the submission was received.
What is the product code of K213341?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.