NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE— 510(k) K132004

Name: FDA 510(k) clearance K132004
Creator: U.S. Food and Drug Administration
Published: 2014-05-02

Substantially Equivalent

Creo Quality, LLC

FDA 510(k) clearance K132004 for NPWT WOUND DRESSING KIT- MEDIUM, NPWT WOUND DRESSING KIT- LARGE, Substantially Equivalent on 2014-05-02. Applicant: Creo Quality, LLC. Device class: 2.

Clearance details

Applicant: Creo Quality, LLC
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2013-07-01
Decision date: 2014-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinsville, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OMP

product code OMP

Death: 31
Injury: 1,707
Malfunction: 4,047
Other: 1
Total: 5,786

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.