ACell, Inc
FDA Regulatory Profile
ACell, Inc appears in FDA public data with 2 recalls, 20 510(k) clearances, 4 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1032-2019, Class II) was initiated on February 14, 2019. Its most recent 510(k) clearance was granted on July 11, 2024.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 20
- Inspections
- 4
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1032-2019 | Class II | Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentr | February 14, 2019 |
| Z-1033-2019 | Class II | Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentr | February 14, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | July 11, 2024 |
| K241706 | MicroMatrix® UBM Particulate | July 11, 2024 |
| K230980 | MicroMatrix® Flex | September 22, 2023 |
| K191734 | MatriStem UBM Pericardial Patch | November 22, 2019 |
| K192725 | Cytal Wound Matrix 3-Layer | October 25, 2019 |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | February 7, 2019 |
| K180776 | Cytal Wound Particulate | May 11, 2018 |
| K172399 | MicroMatrix | October 6, 2017 |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | June 8, 2017 |
| K162554 | Gentrix Surgical Matrix | October 21, 2016 |
| K153754 | MicroMatrix | March 14, 2016 |
| K152721 | Cytal Wound Matrix | December 8, 2015 |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | June 17, 2015 |
| K112409 | MATRISTEM WOUND MATRIX | August 29, 2011 |
| K092926 | ACELL MATRISTEM WOUND SHEET | October 28, 2009 |
| K060888 | ACELL POWDER WOUND DRESSING | June 23, 2006 |
| K041140 | ACELL UBM SURGICAL MESH ML AND MLPLUS | July 7, 2004 |
| K040621 | ACELL UBM SURGICAL MESH | April 14, 2004 |
| K022854 | ACELL UBM HYDRATED WOUND DRESSING | December 30, 2002 |
| K021637 | ACELL UBM LYOPHILIZED WOUND DRESSING | December 19, 2002 |