LTN - Laparoscopic Surgical Mesh
FDA 510(k) K130817 · Lifecell Corp.
510(k) numberK130817
Submission
- Device name
- LTN - Laparoscopic Surgical Mesh
- Applicant
- Lifecell Corp.
Branchburg, NJ, US - Received
- March 25, 2013
- Decision date
- April 17, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OXK – Mesh, Surgical, Collagen, Large Abdominal Wall Defects
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
For reinforcement of soft tissue where weakness exists in abdominal wall defects.
Other 510(k)s with product code OXK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K121289 | Ltm-Labaroscopic Surgical MeshOXK · Traditional | Lifecell Corp. | 08/03/2012SE |
More from Lifecell Corp.
| 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 |
| 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 |
| K082103 | LTM Wound DressingKGN · Traditional | 10/08/2008SE |
| K080353 | Ltm-T Surgical MeshFTL · Traditional | 04/03/2008SE |
Questions and answers
When was LTN - Laparoscopic Surgical Mesh cleared by the FDA?
LTN - Laparoscopic Surgical Mesh (K130817) received a 510(k) decision of Substantially Equivalent on April 17, 2013, 23 days after the submission was received.
What is the product code of K130817?
The FDA product code is OXK – Mesh, Surgical, Collagen, Large Abdominal Wall Defects, a Class II (moderate risk) device regulated under 21 CFR 878.3300.