Data / Medical devices / United States / Acell, Inc.

Acell, Inc.: FDA-registered device maker in Columbia, MD, United States, 15 510(k) clearances

Name: Acell, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Acell, Inc. is registered with the FDA (registration 3005920706) in Columbia, MD, United States. It lists 8 device types. The FDA files 15 510(k) clearances under its listings, the newest dated July 11, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005920706
Address: 6640 Eli Whitney Dr Ste 200, Columbia, MD, United States, 21046
Owner or operator: Integra LifeSciences Corporation (9004007)
Roles: Manufacturer, Specification developer
First device listed: March 24, 2017
Registered through: 2026
Brand names listed: Cardion" for Pericardial Repair, Cytal Burn Matrix, Cytal Wound Matrix 1-Layer, Cytal Wound Matrix 2-Layer, Cytal Wound Matrix 3-Layer, Cytal Wound Matrix 6-Layer, Cytal® Wound Matrix Cytal® Burn Matrix, Gentrix Surgical Matrix and more

Devices it lists

Device	Product code	Class	Role	Source
Bandage, Cast	ITG	1	Specification developer	accessdata.fda.gov
Dressing, Wound, Drug	FRO	U	Specification developer	accessdata.fda.gov
Intracardiac Patch Or Pledget, Biologically Derived	PSQ	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Diaphragmatic Hernia	OWV	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Large Abdominal Wall Defects	OXK	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Manufacturer	accessdata.fda.gov
Wound Dressing With Animal-Derived Material(S)	KGN	U	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 11, 2024	K241724	Cytal® Wound Matrix; Cytal® Burn Matrix	KGN	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
July 11, 2024	K241706	MicroMatrix® UBM Particulate	KGN	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
September 22, 2023	K230980	MicroMatrix® Flex	KGN	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
November 22, 2019	K191734	MatriStem UBM Pericardial Patch	PSQ	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
October 25, 2019	K192725	Cytal Wound Matrix 3-Layer	KGN	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
February 7, 2019	K182259	Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal	FTM	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
October 6, 2017	K172399	MicroMatrix	KGN	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
June 8, 2017	K170763	Gentrix Surgical Matrix Thick; Gentrix Surgical Matrix Extend	FTM	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
December 8, 2015	K152721	Cytal Wound Matrix	KGN	Substantially Equivalent	Acell, Inc.	accessdata.fda.gov
November 19, 2015	K150985	Medihoney Wound Gel	FRO	Substantially Equivalent	Derma Sciences, Inc.	accessdata.fda.gov
July 27, 2011	K110546	MEDIHONEY HYDROGEL SHEET DRESSINGS WITH ACTIVE LEPTOSPERMUM HONEY	FRO	Substantially Equivalent	Derma Sciences, Inc.	accessdata.fda.gov
February 22, 2011	K101793	MEDIHONEY GEL DRESSING WITH ACTIVE MANUKA HONEY	FRO	Substantially Equivalent	Derma Sciences, Inc.	accessdata.fda.gov
April 23, 2008	K080315	DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY	FRO	Substantially Equivalent	Derma Sciences, Inc.	accessdata.fda.gov
November 7, 2007	K072956	MEDIHONEY PRIMARY DRESSINGS WITH ACTIVE MANUKA HONEY	FRO	Substantially Equivalent	Derma Sciences, Inc.	accessdata.fda.gov
July 12, 2007	K053095	HONEY ALGINATE DRESSING	FRO	Substantially Equivalent	Derma Sciences Canada, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 14, 2019	82228	Class II	Terminated	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 requiri	The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.	accessdata.fda.gov
July 7, 2011	59291	Not yet classified	Terminated	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:	Surgical mesh for implantation may have elevated endotoxin levels.	accessdata.fda.gov

Compare with other makers

Updated July 11, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.