SIS WOUND DRESSING II— 510(k) K993948

Name: FDA 510(k) clearance K993948
Creator: U.S. Food and Drug Administration
Published: 2000-01-06

Substantially Equivalent

Cook Biotech, Inc.

FDA 510(k) clearance K993948 for SIS WOUND DRESSING II, Substantially Equivalent on 2000-01-06. 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: 1999-11-22
Decision date: 2000-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Lafayette, IN, US

Download summary PDF View on FDA.gov ↗

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K260596 — Collagen Wound Powder2026-07-02
K260669 — Endoform Dermal Template2026-06-24
K253521 — ECMT-100 WMD2026-06-18

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K133306 — SIS HERNIA GRAFT2014-07-23
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K131015 — BIODESIGN ONLAY DURAL GRAFT OR BIODESIGN DURAPLASTY GRAFT2013-10-08
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.