MicroMatrix® Flex
FDA 510(k) K230980 · Acell, Inc.
510(k) numberK230980
Submission
- Device name
- MicroMatrix® Flex
- Applicant
- Acell, Inc.
Columbia, MD, US - Received
- April 5, 2023
- Decision date
- September 22, 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
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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 |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K241724 | Cytal® Wound Matrix; Cytal® Burn MatrixKGN · Special | 07/11/2024SE |
| K241706 | MicroMatrix® UBM ParticulateKGN · Special | 07/11/2024SE |
| K191734 | MatriStem UBM Pericardial PatchPSQ · Traditional | 11/22/2019SE |
| K192725 | Cytal Wound Matrix 3-LayerKGN · Special | 10/25/2019SE |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalFTM · Traditional | 02/07/2019SE |
| K180776 | Cytal Wound ParticulateKGN · Special | 05/11/2018SE |
| K172399 | MicroMatrixKGN · Traditional | 10/06/2017SE |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendFTM · Traditional | 06/08/2017SE |
| K162554 | Gentrix Surgical MatrixFTM · Special | 10/21/2016SE |
| K153754 | MicroMatrixKGN · Special | 03/14/2016SE |
Questions and answers
When was MicroMatrix® Flex cleared by the FDA?
MicroMatrix® Flex (K230980) received a 510(k) decision of Substantially Equivalent on September 22, 2023, 170 days after the submission was received.
What is the product code of K230980?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.