Medical Device Manufacturer · US , Washington , DC

Acell, Inc.

20 submissions · 20 cleared · Since 2002
20
Total
20
Cleared
0
Denied

Acell, Inc. — FDA 510(k) Submissions

Acell, Inc. has submitted 20 FDA 510(k) premarket notifications since 2002, of which 20 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Wound Dressing With Animal-derived Material(s), Mesh, Surgical, Intracardiac Patch Or Pledget, Biologically Derived . Use the specialty filter in the sidebar to narrow results.

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