MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs— 510(k) K242963
Substantially EquivalentMentor Worldwide, LLC
FDA 510(k) clearance K242963 for MENTOR PliaForm Breast Tissue Expander w/ Suture Tabs, Substantially Equivalent on 2025-04-24. Applicant: Mentor Worldwide, LLC.
Clearance details
- Applicant
- Mentor Worldwide, LLC
- Product code
- Code LCJ
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Adverse events under product code LCJ
product code LCJ- Injury
- 2,704
- Other
- 2
- Total
- 2,706
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.