NOVA SAFE SCALP VEIN BLOOD COLLECTION SET— 510(k) K090502

Substantially Equivalent

U.S. Safety Syringes Co., Inc.

FDA 510(k) clearance K090502 for NOVA SAFE SCALP VEIN BLOOD COLLECTION SET, Substantially Equivalent on 2009-03-10. Applicant: U.S. Safety Syringes Co., Inc..

Clearance details

Applicant: U.S. Safety Syringes Co., Inc.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2009-02-25
Decision date: 2009-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.