LUTH-ALL SUB-Q NEEDLE SET— 510(k) K042666

Substantially Equivalent

Luth-All Medical Products, LLC

FDA 510(k) clearance K042666 for LUTH-ALL SUB-Q NEEDLE SET, Substantially Equivalent on 2004-12-21. Applicant: Luth-All Medical Products, LLC.

Clearance details

Applicant: Luth-All Medical Products, LLC
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2004-09-29
Decision date: 2004-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Niguel, 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.