ARTOURA Breast Tissue Expanders with Smooth Surface— 510(k) K161176

Substantially Equivalent

Mentor Worldwide, LLC

FDA 510(k) clearance K161176 for ARTOURA Breast Tissue Expanders with Smooth Surface, Substantially Equivalent on 2016-05-23. Applicant: Mentor Worldwide, LLC.

Clearance details

Applicant: Mentor Worldwide, LLC
Product code: Code LCJ
Advisory panel: Unknown
Date received: 2016-04-26
Decision date: 2016-05-23
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvin, 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.