LifeCell Corp
Branchburg, NJ, US
LIFECELL CORP appears in FDA device records in Branchburg, NJ. FDA records list 15 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to LifeCell Corp carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- LifeCell Corporation, A Wholly Owned Subsidiary of Allergan PLCenforcement report, recall
510(k) clearance history
FDA records hold 15 510(k) clearances for LifeCell Corp between 2005 and 2020. The busiest year on record is 2007, with 3. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2007 | 3 |
| 2008 | 3 |
| 2012 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 1 |
| 2017 | 2 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193539 | REVOLVE ENVI 600 Advanced Adipose System | MUU | Substantially Equivalent | |
| K163647 | Revolve Envi 600 Advanced Adipose System | MUU | Substantially Equivalent | |
| K162752 | ARTIA Reconstructive Tissue Matrix Perforated | FTM | Substantially Equivalent | |
| K150712 | LTM-Perforated Surgical Mesh | FTM | Substantially Equivalent | |
| K142326 | HP Tissue Matrix | FTM | Substantially Equivalent | |
| K130817 | LTN - LAPAROSCOPIC SURGICAL MESH | OXK | Substantially Equivalent | |
| K112534 | LIFECELL TISSUE EXPANDER | LCJ | Substantially Equivalent | |
| K121289 | LTM-LABAROSCOPIC SURGICAL MESH | OXK | Substantially Equivalent | |
| K082176 | LTM-BPS SURGICAL MESH | FTM | Substantially Equivalent | |
| K082103 | LTM WOUND DRESSING | KGN | Substantially Equivalent | |
| K080353 | LTM-T SURGICAL MESH | FTL | Substantially Equivalent | |
| K071986 | LTM-RC SURGICAL MESH | FTM | Substantially Equivalent | |
| K070560 | LRTM SURGICAL MESH | FTM | Substantially Equivalent | |
| K061208 | LIFECELL DURAL SUBSTITUTE MATRIX | GXQ | Substantially Equivalent | |
| K052735 | ALLOCRAFT DBM | MBP | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016823837 | 3016823837 | LIFECELL CORP | 4 Millenium Way, Branchburg, NJ 08876 US | 2026 | |
| 1647098 | 1000306051 | LIFECELL CORP. | ONE MILLENNIUM WAY, BRANCHBURG, NJ 08876 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NPLBarrier, Animal Source, Intraoral
- GXQDura Substitute
- MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)
- QKLLipoaspirate Washing System For Aesthetic Body Contouring
- FTMMesh, Surgical
- OXKMesh, Surgical, Collagen, Large Abdominal Wall Defects
- OXHMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
- FTLMesh, Surgical, Polymeric
- MUUSystem, Suction, Lipoplasty
- LCJTissue Expander And Accessories
- KGNWound Dressing With Animal-Derived Material(S)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0823-2018 | 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 | Class II | Terminated | |
| Z-0178-2012 | 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 weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. | 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. | Terminated | ||
| Z-0162-2011 | 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. | Terminated | ||
| Z-2623-2010 | 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 Strattice is intended for use as a foil tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. It is used for repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome. It is intended for single patient one time use. | Mislabeled -One lot of product labeled as 8 cm x 8 cm were actually cut using a 6 cm x 6 cm template. | Terminated | ||
| Z-1299-2008 | AlloCraft DBM with Syringe Assembly, 10 CC, 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) | Terminated | ||
| Z-1298-2008 | 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) | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain