ACell, Inc

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
20
Inspections
4
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1032-2019Class IIGentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: GentrFebruary 14, 2019
Z-1033-2019Class IIGentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: GentrFebruary 14, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K241706MicroMatrix® UBM ParticulateJuly 11, 2024
K241724Cytal® Wound Matrix; Cytal® Burn MatrixJuly 11, 2024
K230980MicroMatrix® FlexSeptember 22, 2023
K191734MatriStem UBM Pericardial PatchNovember 22, 2019
K192725Cytal Wound Matrix 3-LayerOctober 25, 2019
K182259Gentrix Surgical Matrix, Gentrix Surgical Matrix HiatalFebruary 7, 2019
K180776Cytal Wound ParticulateMay 11, 2018
K172399MicroMatrixOctober 6, 2017
K170763Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix ExtendJune 8, 2017
K162554Gentrix Surgical MatrixOctober 21, 2016
K153754MicroMatrixMarch 14, 2016
K152721Cytal Wound MatrixDecember 8, 2015
K141084Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor MatrixJune 17, 2015
K112409MATRISTEM WOUND MATRIXAugust 29, 2011
K092926ACELL MATRISTEM WOUND SHEETOctober 28, 2009
K060888ACELL POWDER WOUND DRESSINGJune 23, 2006
K041140ACELL UBM SURGICAL MESH ML AND MLPLUSJuly 7, 2004
K040621ACELL UBM SURGICAL MESHApril 14, 2004
K022854ACELL UBM HYDRATED WOUND DRESSINGDecember 30, 2002
K021637ACELL UBM LYOPHILIZED WOUND DRESSINGDecember 19, 2002