OASIS WOUND MATRIX— 510(k) K061711

Name: FDA 510(k) clearance K061711
Creator: U.S. Food and Drug Administration
Published: 2006-07-19

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K061711 for OASIS WOUND MATRIX, Substantially Equivalent on 2006-07-19. Applicant: Cook Biotech, Inc.. Device class: Unclassified.

Clearance details

Applicant: Cook Biotech, Inc.
Product code: Code KGN
Device class: Unclassified
Advisory panel: Unknown
Date received: 2006-06-19
Decision date: 2006-07-19
Decision: Substantially Equivalent
Clearance type: Special
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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K253521 — ECMT-100 WMD2026-06-18

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K111695 — HYBRID GRAFT2012-04-02
K110402 — BIODESIGN NIPPLE RECONSTRUCTION CYLINDER2011-06-20

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.