ENDURAMESH— 510(k) K122622

Substantially Equivalent

Lucero Medical, LLC

FDA 510(k) clearance K122622 for ENDURAMESH, Substantially Equivalent on 2012-09-19. Applicant: Lucero Medical, LLC.

Clearance details

Applicant: Lucero Medical, LLC
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2012-08-28
Decision date: 2012-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Avon Lake, OH, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.