MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS— 510(k) K033039

Substantially Equivalent

Mckinley, Inc.

FDA 510(k) clearance K033039 for MODIFICATION TO: ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KITS, Substantially Equivalent on 2003-10-07. Applicant: Mckinley, Inc..

Clearance details

Applicant: Mckinley, Inc.
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2003-09-29
Decision date: 2003-10-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Wheat Ridge, CO, US

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Adverse events under product code MEB

product code MEB

Death: 6
Injury: 160
Malfunction: 10,053
Other: 5
Total: 10,224

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.