LTM-Perforated Surgical Mesh— 510(k) K150712
Substantially EquivalentLifecell Corporation
FDA 510(k) clearance K150712 for LTM-Perforated Surgical Mesh, Substantially Equivalent on 2015-07-02. Applicant: Lifecell Corporation. Device class: 2.
Clearance details
- Applicant
- Lifecell Corporation
- Product code
- Code FTM
- Device class
- Class 2
- Regulation
- 21 CFR 878.3300
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Recent devices under product code FTM
view allMore clearances from Lifecell Corporation
view allAdverse events under product code FTM
product code FTM- Death
- 17
- Injury
- 2,174
- Total
- 2,191
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.