Medical Device Manufacturer · US , Washington , DC

Acell, Inc. - FDA 510(k) Cleared Devices

20 submissions · 20 cleared · Since 2002

Recent clearances: MicroMatrix® UBM Particulate, Cytal® Wound Matrix, MicroMatrix® Flex

20
Total
20
Cleared
0
Denied

Acell, Inc. has 20 FDA 510(k) cleared general & plastic surgery devices. Based in Washington, US.

Latest FDA clearance: Jul 2024. Active since 2002.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Hogan Lovells and Hogan Lovells US LLP.

FDA 510(k) Regulatory Record - Acell, Inc.

20 devices
1-20 of 20
Cleared Jul 11, 2024
MicroMatrix® UBM Particulate
K241706 · KGN
General & Plastic Surgery · 28d
Cleared Jul 11, 2024
Cytal® Wound Matrix
K241724 · KGN
General & Plastic Surgery · 27d
Cleared Sep 22, 2023
MicroMatrix® Flex
K230980 · KGN
General & Plastic Surgery · 170d
Cleared Nov 22, 2019
MatriStem UBM Pericardial Patch
K191734 · PSQ
Cardiovascular · 147d
Cleared Oct 25, 2019
Cytal Wound Matrix 3-Layer
K192725 · KGN
General & Plastic Surgery · 28d
Cleared Feb 07, 2019
Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal
K182259 · FTM
General & Plastic Surgery · 170d
Cleared May 11, 2018
Cytal Wound Particulate
K180776 · KGN
General & Plastic Surgery · 49d
Cleared Oct 06, 2017
MicroMatrix
K172399 · KGN
General & Plastic Surgery · 59d
Cleared Jun 08, 2017
Gentrix Surgical Matrix Thick
K170763 · FTM
General & Plastic Surgery · 87d
Cleared Oct 21, 2016
Gentrix Surgical Matrix
K162554 · FTM
General & Plastic Surgery · 38d
Cleared Mar 14, 2016
MicroMatrix
K153754 · KGN
General & Plastic Surgery · 76d
Cleared Dec 08, 2015
Cytal Wound Matrix
K152721 · KGN
General & Plastic Surgery · 78d
Cleared Jun 17, 2015
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix
K141084 · FTM
General & Plastic Surgery · 415d
Cleared Aug 29, 2011
MATRISTEM WOUND MATRIX
K112409 · KGN
General & Plastic Surgery · 7d
Cleared Oct 28, 2009
ACELL MATRISTEM WOUND SHEET
K092926 · KGN
General & Plastic Surgery · 35d
Cleared Jun 23, 2006
ACELL POWDER WOUND DRESSING
K060888 · KGN
General & Plastic Surgery · 84d
Cleared Jul 07, 2004
ACELL UBM SURGICAL MESH ML AND MLPLUS
K041140 · FTM
General & Plastic Surgery · 68d
Cleared Apr 14, 2004
ACELL UBM SURGICAL MESH
K040621 · FTM
General & Plastic Surgery · 36d
Cleared Dec 30, 2002
ACELL UBM HYDRATED WOUND DRESSING
K022854 · KGN
General & Plastic Surgery · 137d
Cleared Dec 19, 2002
ACELL UBM LYOPHILIZED WOUND DRESSING
K021637 · KGN
General & Plastic Surgery · 216d
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