FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK— 510(k) K140967

Name: FDA 510(k) clearance K140967
Creator: U.S. Food and Drug Administration
Published: 2014-06-10

Substantially Equivalent

Insightra Medical

FDA 510(k) clearance K140967 for FREEDOM INGUINAL HERNIA REPAIR IMPLANT-25MM/40MM/40MM WITH EXTENDED DISK, Substantially Equivalent on 2014-06-10. Applicant: Insightra Medical. Device class: 2.

Clearance details

Applicant: Insightra Medical
Product code: Product code FTL
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2014-04-14
Decision date: 2014-06-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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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.