Company ยท US
Lifecell Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2020. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
5recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FTM | Mesh, Surgical | 8 |
| MQV | Filler, Bone Void, Calcium Compound | 2 |
| MUU | System, Suction, Lipoplasty | 2 |
| OXK | Mesh, Surgical, Collagen, Large Abdominal Wall Defects | 2 |
| FTL | Mesh, Surgical, Polymeric | 1 |
| GXQ | Dura Substitute | 1 |
| KGN | Wound Dressing With Animal-Derived Material(S) | 1 |
| KGZ | Accessories, Catheter | 1 |
| LCJ | Tissue Expander And Accessories | 1 |
| MBP | Filler, Bone Void, Osteoinduction (W/O Human Growth Factor) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 28, 2020 | K193539 | REVOLVE ENVI 600 Advanced Adipose System Lifecell Corporation | MUU |
| Aug 25, 2017 | K163647 | Revolve Envi 600 Advanced Adipose System Lifecell Corporation | MUU |
| Feb 24, 2017 | K162752 | ARTIA Reconstructive Tissue Matrix Perforated Lifecell Corporation | FTM |
| Jul 2, 2015 | K150712 | LTM-Perforated Surgical Mesh Lifecell Corporation | FTM |
| Dec 23, 2014 | K142326 | HP Tissue Matrix Lifecell Corporation | FTM |
| Apr 17, 2013 | K130817 | LTN - LAPAROSCOPIC SURGICAL MESH Lifecell Corp. | OXK |
| Aug 10, 2012 | K112534 | LIFECELL TISSUE EXPANDER Lifecell Corp. | LCJ |
| Aug 3, 2012 | K121289 | LTM-LABAROSCOPIC SURGICAL MESH Lifecell Corp. | OXK |
| Nov 14, 2008 | K082176 | LTM-BPS SURGICAL MESH Lifecell Corp. | FTM |
| Oct 8, 2008 | K082103 | LTM WOUND DRESSING Lifecell Corp. | KGN |
| Apr 3, 2008 | K080353 | LTM-T SURGICAL MESH Lifecell Corp. | FTL |
| Oct 19, 2007 | K071986 | LTM-RC SURGICAL MESH Lifecell Corp. | FTM |
| Jun 11, 2007 | K070560 | LRTM SURGICAL MESH Lifecell Corp. | FTM |
| Jan 3, 2007 | K061208 | LIFECELL DURAL SUBSTITUTE MATRIX Lifecell Corp. | GXQ |
| Dec 28, 2005 | K052735 | ALLOCRAFT DBM Lifecell Corp. | MBP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2011 | LifeCell Corporation 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 reinfo Terminated |
FTM | K070560 |
| Oct 28, 2010 | LifeCell Corporation IV Catheter - Optiva IV Catheter. This is found in box labeled 'Graft Jacket Xpress Flowable Soft Tissue Scaffold'; labeled by Wright. Terminated |
KGZ | None listed |
| Sep 29, 2010 | LifeCell Corporation 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, Branchbur Terminated |
FTM | K070560 |
| Mar 26, 2008 | LifeCell Corporation AlloCraft DBM with Syringe Assembly, 10 CC, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine Terminated |
MQV | K052735 |
| Mar 26, 2008 | LifeCell Corporation AlloCraft DBM with Syringe Assembly, 5CC, Catalog/Reorder Number: 653005, LifeCell Corporation, Branchburg, NJ 08876 , Distributed by Stryker Spine Terminated |
MQV | K052735 |