ACell, Inc
Columbia, MD, US
ACELL, INC. appears in FDA device records in Columbia, MD. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for ACell, Inc between 2009 and 2024. The busiest year on record is 2019, with 3. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2011 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 2 |
| 2018 | 1 |
| 2019 | 3 |
| 2023 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241724 | Cytal® Wound Matrix; Cytal® Burn Matrix | KGN | Substantially Equivalent | |
| K241706 | MicroMatrix® UBM Particulate | KGN | Substantially Equivalent | |
| K230980 | MicroMatrix® Flex | KGN | Substantially Equivalent | |
| K191734 | MatriStem UBM Pericardial Patch | PSQ | Substantially Equivalent | |
| K192725 | Cytal Wound Matrix 3-Layer | KGN | Substantially Equivalent | |
| K182259 | Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal | FTM | Substantially Equivalent | |
| K180776 | Cytal Wound Particulate | KGN | Substantially Equivalent | |
| K172399 | MicroMatrix | KGN | Substantially Equivalent | |
| K170763 | Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend | FTM | Substantially Equivalent | |
| K162554 | Gentrix Surgical Matrix | FTM | Substantially Equivalent | |
| K153754 | MicroMatrix | KGN | Substantially Equivalent | |
| K152721 | Cytal Wound Matrix | KGN | Substantially Equivalent | |
| K141084 | Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix | FTM | Substantially Equivalent | |
| K112409 | MATRISTEM WOUND MATRIX | KGN | Substantially Equivalent | |
| K092926 | ACELL MATRISTEM WOUND SHEET | KGN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005920706 | 3005920706 | ACELL, INC. | 6640 Eli Whitney Dr Ste 200, Columbia, MD 21046 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ITGBandage, Cast
- FRODressing, Wound, Drug
- PSQIntracardiac Patch Or Pledget, Biologically Derived
- FTMMesh, Surgical
- OWVMesh, Surgical, Collagen, Diaphragmatic Hernia
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1033-2019 | 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 in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair. | The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. | Class II | Terminated | |
| Z-1032-2019 | 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 in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair. | The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release. | Class II | Terminated | |
| Z-2855-2011 | 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 following procedures: pubourethral support, tissue repair, body wall repair, and esophageal repair | Surgical mesh for implantation may have elevated endotoxin levels. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain