INTEGRA WOUND MATRIX (THIN)— 510(k) K113104

Name: FDA 510(k) clearance K113104
Creator: U.S. Food and Drug Administration
Published: 2012-02-09

Substantially Equivalent

Integra LifeSciences Corporation

FDA 510(k) clearance K113104 for INTEGRA WOUND MATRIX (THIN), Substantially Equivalent on 2012-02-09. Applicant: Integra LifeSciences Corporation. Device class: Unclassified.

Clearance details

Applicant: Integra LifeSciences Corporation
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-10-20
Decision date: 2012-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planisboro, NJ, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KGN

product code KGN

Other: 2
Total: 2

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.