Exogenesis Hernia Mesh— 510(k) K191545

Substantially Equivalent

Exogenesis Corporation

FDA 510(k) clearance K191545 for Exogenesis Hernia Mesh, Substantially Equivalent on 2019-09-26. Applicant: Exogenesis Corporation.

Clearance details

Applicant: Exogenesis Corporation
Product code: Code FTL
Advisory panel: General, Plastic Surgery
Date received: 2019-06-11
Decision date: 2019-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FTL

product code FTL

Death: 317
Injury: 66,072
Malfunction: 1,273
Other: 3
Total: 67,665

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.