ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER— 510(k) K092619

Substantially Equivalent

Civco

FDA 510(k) clearance K092619 for ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER, Substantially Equivalent on 2009-11-13. Applicant: Civco.

Clearance details

Applicant: Civco
Product code: Code IYO
Advisory panel: Radiology
Date received: 2009-08-26
Decision date: 2009-11-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalona, IA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.