LTM-Perforated Surgical Mesh
FDA 510(k) K150712 · Lifecell Corporation
510(k) numberK150712
Submission
- Device name
- LTM-Perforated Surgical Mesh
- Applicant
- Lifecell Corporation
Branchburg, NJ, US - Received
- March 19, 2015
- Decision date
- July 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FTM – Mesh, Surgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
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| 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 |
| K082103 | LTM Wound DressingKGN · Traditional | 10/08/2008SE |
| K080353 | Ltm-T Surgical MeshFTL · Traditional | 04/03/2008SE |
Questions and answers
When was LTM-Perforated Surgical Mesh cleared by the FDA?
LTM-Perforated Surgical Mesh (K150712) received a 510(k) decision of Substantially Equivalent on July 2, 2015, 105 days after the submission was received.
What is the product code of K150712?
The FDA product code is FTM – Mesh, Surgical, a Class II (moderate risk) device regulated under 21 CFR 878.3300.