K191749 is an FDA 510(k) clearance for the TIGR Matrix Surgical Mesh, TIGR Surgical Mesh. Classified as Mesh, Surgical, Absorbable, Abdominal Hernia (product code OWT), Class II - Special Controls.
Submitted by Novus Scientific AB (Uppsala, SE). The FDA issued a Cleared decision on March 26, 2020 after a review of 269 days - an extended review cycle.
This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.3300 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.
Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.
View all Novus Scientific AB devices
NCT01622725
Completed
Interventional
Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
Recurrence Rate After Primary and Secondary Ventral Hernia Repair Using Long-term Resorbable Versus Non-resorbable Large Pore Synthetic Mesh.
| Condition studied |
Primary and Secondary Ventral Hernia |
| Study design |
Parallel |
| Eligibility |
All sexes
· 18 Years+
|
| Principal investigator |
Frederik Berrevoet, MD, PhD |
| Sponsor |
University Hospital, Ghent
|
Started 2013-02-01
→
Primary completion 2021-08-01
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Completed 2023-12-31
Primary outcome
Recurrence rate at 3 years post-surgery.
Secondary outcome
Wound Morbidity 4 weeks post-surgery.
Study completed - no results published.
This trial concluded in 2023 but has not posted
results to ClinicalTrials.gov. Completed studies without public results are common
in industry-sponsored device trials; the data may be referenced in the
510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov