DeviceClearance

CPX 4 Breast Tissue Expander with Smooth Surface— 510(k) K182335

Substantially Equivalent

Mentor Worldwide, LLC

FDA 510(k) clearance K182335 for CPX 4 Breast Tissue Expander with Smooth Surface, Substantially Equivalent on 2018-09-25. 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
Special
Location
Irvin, CA, US
Download summary PDFView on FDA.gov ↗

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.