Company · US
Acell, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2024. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 11, 2024 | K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix Acell, Inc. | KGN |
| Jul 11, 2024 | K241706 | MicroMatrix® UBM Particulate Acell, Inc. | KGN |
| Sep 22, 2023 | K230980 | MicroMatrix® Flex Acell, Inc. | KGN |
| Nov 22, 2019 | K191734 | MatriStem UBM Pericardial Patch Acell, Inc. | PSQ |
| Oct 25, 2019 | K192725 | Cytal Wound Matrix 3-Layer Acell, Inc. | KGN |
| Feb 7, 2019 | K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal Acell, Inc. | FTM |
| May 11, 2018 | K180776 | Cytal Wound Particulate Acell, Inc. | KGN |
| Oct 6, 2017 | K172399 | MicroMatrix Acell, Inc. | KGN |
| Jun 8, 2017 | K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend Acell, Inc. | FTM |
| Oct 21, 2016 | K162554 | Gentrix Surgical Matrix Acell, Inc. | FTM |
| Mar 14, 2016 | K153754 | MicroMatrix Acell, Inc. | KGN |
| Dec 8, 2015 | K152721 | Cytal Wound Matrix Acell, Inc. | KGN |
| Jun 17, 2015 | K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix Acell, Inc. | FTM |
| Aug 29, 2011 | K112409 | MATRISTEM WOUND MATRIX Acell, Inc. | KGN |
| Oct 28, 2009 | K092926 | ACELL MATRISTEM WOUND SHEET Acell, Inc. | KGN |
| Jun 23, 2006 | K060888 | ACELL POWDER WOUND DRESSING Acell, Inc. | KGN |
| Jul 7, 2004 | K041140 | ACELL UBM SURGICAL MESH ML AND MLPLUS Acell, Inc. | FTM |
| Apr 14, 2004 | K040621 | ACELL UBM SURGICAL MESH Acell, Inc. | FTM |
| Dec 30, 2002 | K022854 | ACELL UBM HYDRATED WOUND DRESSING Acell, Inc. | KGN |
| Dec 19, 2002 | K021637 | ACELL UBM LYOPHILIZED WOUND DRESSING Acell, Inc. | KGN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2019 | ACell, Inc Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists Terminated |
FTM | K170763 |
| Feb 14, 2019 | ACell, Inc Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists Terminated |
FTM | K170763 |
| Jul 21, 2011 | ACell, Inc MatriStem Plastic Surgery Matrix XS
Intended for implantation to reinforce tissue where weakness exists in urological, gynecological, and gastrointestinal anatomy, including, but not limited to the Terminated |
FTM | None listed |