LUTHER SAFETY HUBER NEEDLE SET— 510(k) K021565

Substantially Equivalent

Luther Research Partners

FDA 510(k) clearance K021565 for LUTHER SAFETY HUBER NEEDLE SET, Substantially Equivalent on 2002-11-14. Applicant: Luther Research Partners.

Clearance details

Applicant: Luther Research Partners
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2002-05-13
Decision date: 2002-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.