CPX 4 Breast Tissue Expander— 510(k) K152496

Substantially Equivalent

Mentor Worldwide, LLC

FDA 510(k) clearance K152496 for CPX 4 Breast Tissue Expander, Substantially Equivalent on 2016-02-19. Applicant: Mentor Worldwide, LLC.

Clearance details

Applicant: Mentor Worldwide, LLC
Product code: Code LCJ
Advisory panel: Unknown
Date received: 2015-09-01
Decision date: 2016-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, 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.