Data / Medical devices / United States / Lifecell Corp.

Lifecell Corp.: FDA-registered device maker in Branchburg, NJ, United States, 6 510(k) clearances

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

Lifecell Corp. is registered with the FDA (registration 1647098) in Branchburg, NJ, United States. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 24, 2017. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Lifecell Corp.

FDA registration number: 1647098
FEI number: 1000306051
Address: One Millennium Way, Branchburg, NJ, United States, 08876
Owner or operator: AbbVie, Inc. (2011068)
Roles: Complaint file establishment, Manufacturer, Manufacturer for export
First device listed: May 30, 2017
Registered through: 2027
Brand names listed: ARTIA RECONSTRUCTIVE TISSUE MATRIX; HP Tissue Matrix, ARTIA Reconstructive Tissue Matrix Perforated, GID 700; Revolve; The Revolve System, NovoMatrix Reconstructive Tissue Matrix, REVOLVE ENVI 600 Advanced Adipose System, Strattice Reconstructive Tissue Matrix (RTM) Laparoscopic, Strattice Reconstructive Tissue Matrix (RTM) Perforated, Strattice Reconstructive Tissue Matrix (RTM); Strattice Reconstructive Tissue Matrix BPS and more

Devices it lists

Device	Product code	Class	Role	Source
Barrier, Animal Source, Intraoral	NPL	2	Manufacturer for export	accessdata.fda.gov
Lipoaspirate Washing System For Aesthetic Body Contouring	QKL	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Large Abdominal Wall Defects	OXK	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery	OXH	2	Complaint file establishment, 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
February 24, 2017	K162752	ARTIA Reconstructive Tissue Matrix Perforated	FTM	Substantially Equivalent	Lifecell Corporation	accessdata.fda.gov
July 2, 2015	K150712	LTM-Perforated Surgical Mesh	FTM	Substantially Equivalent	Lifecell Corporation	accessdata.fda.gov
December 23, 2014	K142326	HP Tissue Matrix	FTM	Substantially Equivalent	Lifecell Corporation	accessdata.fda.gov
April 17, 2013	K130817	LTN - LAPAROSCOPIC SURGICAL MESH	OXK	Substantially Equivalent	Lifecell Corp.	accessdata.fda.gov
November 14, 2008	K082176	LTM-BPS SURGICAL MESH	FTM	Substantially Equivalent	Lifecell Corp.	accessdata.fda.gov
June 11, 2007	K070560	LRTM SURGICAL MESH	FTM	Substantially Equivalent	Lifecell Corp.	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
August 8, 2017	79136	Class II	Terminated	REVOLVE ADVANCED ADIPOSE SYSTEM, for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring.	Presence of bacterial endotoxins levels above the acceptable limit	accessdata.fda.gov
July 13, 2011	60104	Not yet classified	Terminated	LifeCell Strattice Reconstructive Tissue Matrix for Stoma Reinforcement Catalog #0606008 (6 x 6 cm), 0808008 (8 cm x 8 cm), (0610008 ( 6 cm x 10 cm). Intended for use as a soft tissue patch to reinforce soft tissue where	The use of Strattice for stoma reinforcement at the time of stoma creation is not within the product's cleared indications for use in the US market.	accessdata.fda.gov
September 13, 2010	56826	Not yet classified	Terminated	IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright.	Graft Jacket Xpress kits contain catheters that will expire or have already expired prior to the labeled expiration of the human tissue component of the product on the outer box.	accessdata.fda.gov
July 12, 2010	56261	Not yet classified	Terminated	Strattice Reconstructive Tissue Matrix for Stoma Reinforcement. 8 cm x 8 cm Packaged in an inner foil pouch inside outer foil pouch tertiary carton. LifeCell Corporation, One Millennium Way, Branchburg, NJ 08876 Strattic	Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template.	accessdata.fda.gov
October 17, 2007	46780	Not yet classified	Terminated	AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876, Distributed by Stryker Spine	Improper donor screening test; diagnostic test kits were used in lieu of a donor screening test kits for HBsAG and HBcAB (later re-testing with FDA-approved donor screening test found samples non-reactive for both Hepatitis B Surface Antigen and Hepatitis B Core IgM/IgG Antibody)	accessdata.fda.gov

Compare with other makers

Updated February 24, 2017. 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.