HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE— 510(k) K041399

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K041399 for HYPODERMIC NEEDLE-PRO EDGE NEEDLE PROTECTION DEVICE, Substantially Equivalent on 2004-07-28. Applicant: Smiths Medical Asd, Inc..

Clearance details

Applicant: Smiths Medical Asd, Inc.
Product code: Code FMI
Advisory panel: General Hospital
Date received: 2004-05-26
Decision date: 2004-07-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Keene, NH, US

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Adverse events under product code FMI

product code FMI

Death: 28
Injury: 1,517
Malfunction: 23,981
Other: 18
Total: 25,544

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.