TIGR Matrix Surgical Mesh, TIGR Surgical Mesh— 510(k) K191749

Name: FDA 510(k) clearance K191749
Creator: U.S. Food and Drug Administration
Published: 2020-03-26

Substantially Equivalent

Novus Scientific AB

FDA 510(k) clearance K191749 for TIGR Matrix Surgical Mesh, TIGR Surgical Mesh, Substantially Equivalent on 2020-03-26. Applicant: Novus Scientific AB. Device class: 2.

Clearance details

Applicant: Novus Scientific AB
Product code: Code OWT
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2019-07-01
Decision date: 2020-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Uppsala, SE

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OWT

product code OWT

Death: 3
Injury: 396
Total: 399

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.