Acell, Inc.
Medical device manufacturer in Columbia, MD.
20510(k) clearances
0PMA approvals
3recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K241724 | Cytal® Wound Matrix; Cytal® Burn MatrixKGN · Special | 07/11/2024SE |
| K241706 | MicroMatrix® UBM ParticulateKGN · Special | 07/11/2024SE |
| K230980 | MicroMatrix® FlexKGN · Traditional | 09/22/2023SE |
| 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 |
| K152721 | Cytal Wound MatrixKGN · Special | 12/08/2015SE |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixFTM · Traditional | 06/17/2015SE |
| K112409 | Matristem Wound MatrixKGN · Special | 08/29/2011SE |
| K092926 | Acell Matristem Wound SheetKGN · Special | 10/28/2009SE |
| K060888 | Acell Powder Wound DressingKGN · Traditional | 06/23/2006SE |
| K041140 | Acell Ubm Surgical Mesh ML and MlplusFTM · Abbreviated | 07/07/2004SE |
| K040621 | Acell Ubm Surgical MeshFTM · Abbreviated | 04/14/2004SE |
| K022854 | Acell Ubm Hydrated Wound DressingKGN · Traditional | 12/30/2002SE |
| K021637 | Acell Ubm Lyophilized Wound DressingKGN · Traditional | 12/19/2002SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1033-2019 Class II | Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product…The devices were released from a lot for which one sample failed to meet the company' s tensile strength… | 02/14/2019Terminated |
| Z-1032-2019 Class II | Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product…The devices were released from a lot for which one sample failed to meet the company' s tensile strength… | 02/14/2019Terminated |
| Z-2855-2011 | MatriStem Plastic Surgery Matrix XS Intended for implantation to reinforce tissue where…Surgical mesh for implantation may have elevated endotoxin levels. | 07/07/2011Terminated |