SVED WOUND TREATMENT SYSTEM— 510(k) K093564

Name: FDA 510(k) clearance K093564
Creator: U.S. Food and Drug Administration
Published: 2009-11-25

Substantially Equivalent

Innovative Therapies, Inc.

FDA 510(k) clearance K093564 for SVED WOUND TREATMENT SYSTEM, Substantially Equivalent on 2009-11-25. Applicant: Innovative Therapies, Inc.. Device class: 2.

Clearance details

Applicant: Innovative Therapies, Inc.
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2009-11-18
Decision date: 2009-11-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Gaithersburg, MD, 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.