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 3016823837) 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. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Lifecell Corp

FDA registration number: 3016823837
Address: 4 Millenium Way, Branchburg, NJ, United States, 08876
Owner or operator: AbbVie, Inc. (2011068)
Roles: 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	Manufacturer	accessdata.fda.gov
Mesh, Surgical	FTM	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

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

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.