LTM Wound Dressing
FDA 510(k) K082103 · Lifecell Corp.
510(k) numberK082103
Submission
- Device name
- LTM Wound Dressing
- Applicant
- Lifecell Corp.
Branchburg, NJ, US - Received
- July 25, 2008
- Decision date
- October 8, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KGN – Wound Dressing With Animal-Derived Material(S)
- Device class
- Unclassified
- Implant
- Yes
Other 510(k)s with product code KGN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260652 | ColActive PlusKGN · Traditional | Covalon Technologies, Ltd. | 09/09/2026SE |
| K260711 | Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc…KGN · Traditional | Berkeley Advanced Biomaterials | 08/27/2026SE |
| K260596 | Collagen Wound PowderKGN · Traditional | Ventris Medical | 07/02/2026SE |
| K260669 | Endoform Dermal TemplateKGN · Traditional | Aroa Biosurgery , Ltd. | 06/24/2026SE |
| K253521 | ECMT-100 WMDKGN · Traditional | Ecm Therapeutics, Inc. | 06/18/2026SE |
| K253204 | CatalyzeKGN · Traditional | BioTissue Holdings, Inc. | 06/05/2026SE |
| K254034 | Roosin Collagen PowderKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K253974 | Roosin Collagen DressingKGN · Traditional | Roosin Medical Co., Ltd. | 06/03/2026SE |
| K261224 | MatriDermKGN · Special | Medskin Solutions Dr. Suwelack AG | 05/14/2026SE |
| K260532 | Derma-GideKGN · Special | Geistlich Pharma AG | 03/19/2026SE |
More from Geistlich Pharma AG
| 510(k) | Device | Decision |
|---|---|---|
| K193539 | REVOLVE ENVI 600 Advanced Adipose SystemMUU · Traditional | 05/28/2020SE |
| K163647 | Revolve Envi 600 Advanced Adipose SystemMUU · Traditional | 08/25/2017SE |
| K162752 | ARTIA Reconstructive Tissue Matrix PerforatedFTM · Traditional | 02/24/2017SE |
| K150712 | LTM-Perforated Surgical MeshFTM · Traditional | 07/02/2015SE |
| K142326 | HP Tissue MatrixFTM · Traditional | 12/23/2014SE |
| K130817 | LTN - Laparoscopic Surgical MeshOXK · Special | 04/17/2013SE |
| K112534 | Lifecell Tissue ExpanderLCJ · Traditional | 08/10/2012SE |
| K121289 | Ltm-Labaroscopic Surgical MeshOXK · Traditional | 08/03/2012SE |
| K082176 | Ltm-Bps Surgical MeshFTM · Traditional | 11/14/2008SE |
| K080353 | Ltm-T Surgical MeshFTL · Traditional | 04/03/2008SE |
Questions and answers
When was LTM Wound Dressing cleared by the FDA?
LTM Wound Dressing (K082103) received a 510(k) decision of Substantially Equivalent on October 8, 2008, 75 days after the submission was received.
What is the product code of K082103?
The FDA product code is KGN – Wound Dressing With Animal-Derived Material(S), a Unclassified device.