NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET— 510(k) K011297

Substantially Equivalent

Nipro Medical Corp.

FDA 510(k) clearance K011297 for NIPRO SAFETOUCH SCALP VEIN AND BLOOD COLLECTION SET, Substantially Equivalent on 2001-06-20. Applicant: Nipro Medical Corp..

Clearance details

Applicant: Nipro Medical Corp.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 2001-04-30
Decision date: 2001-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, KY, US

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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.