Mentor CPX 4 PLUS Enhance Breast Tissue Expander— 510(k) K243836

Substantially Equivalent

Mentor Worldwide, LLC

FDA 510(k) clearance K243836 for Mentor CPX 4 PLUS Enhance Breast Tissue Expander, Substantially Equivalent on 2025-01-12. Applicant: Mentor Worldwide, LLC.

Clearance details

Applicant: Mentor Worldwide, LLC
Product code: Code LCJ
Advisory panel: Unknown
Date received: 2024-12-13
Decision date: 2025-01-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LCJ

product code LCJ

Injury: 2,704
Other: 2
Total: 2,706

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.