MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT— 510(k) K050770

Name: FDA 510(k) clearance K050770
Creator: U.S. Food and Drug Administration
Published: 2005-04-14

Substantially Equivalent

Mckinley Medical, LLC

FDA 510(k) clearance K050770 for MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT, Substantially Equivalent on 2005-04-14. Applicant: Mckinley Medical, LLC. Device class: 2.

Clearance details

Applicant: Mckinley Medical, LLC
Product code: Code MEB
Device class: Class 2
Regulation: 21 CFR 880.5725
Advisory panel: General Hospital
Date received: 2005-03-25
Decision date: 2005-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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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.