ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT— 510(k) K023098

Substantially Equivalent

Mckinley Infuser

FDA 510(k) clearance K023098 for ACCUFUSER, ACCUFUSER PLUS, STANDARD PROCEDURE KIT, ACCUFUSER INFUSION KIT, Substantially Equivalent on 2002-12-09. Applicant: Mckinley Infuser.

Clearance details

Applicant: Mckinley Infuser
Product code: Code MEB
Advisory panel: General Hospital
Date received: 2002-09-18
Decision date: 2002-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, 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.