NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900— 510(k) K032301

Name: FDA 510(k) clearance K032301
Creator: U.S. Food and Drug Administration
Published: 2003-08-21

Substantially Equivalent

Neogen Technologies, Inc.

FDA 510(k) clearance K032301 for NEOGEN ONE, CLOSED WOUND DRAIN SYSTEM, PART NUMBER: NG9900, Substantially Equivalent on 2003-08-21. Applicant: Neogen Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Neogen Technologies, Inc.
Product code: Code OMP
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 2003-07-25
Decision date: 2003-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ft Lauderdale, FL, US

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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.