510(k) K092619 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER
| Applicant | Civco, Kalona IA, US |
| Decision | Substantially Equivalent, Nov 13, 2009 |
| Received | Aug 26, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092619
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 Open, Classified |
IYO | None listed |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 Open, Classified |
IYO | None listed |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 Open, Classified |
IYO | None listed |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 Open, Classified |
IYO | None listed |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 Open, Classified |
IYO | None listed |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 Open, Classified |
IYO | None listed |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 Open, Classified |
IYO | None listed |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 Open, Classified |
IYO | None listed |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX Terminated |
IYO | None listed |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX Terminated |
IYO | None listed |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, Sensor with 10 17 GA
VirtutTRAX Terminated |
IYO | None listed |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX Terminated |
IYO | None listed |
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX instrument navigator and (8.9 tapered to 1.3 x 147cm) telesco Terminated |
IYO | None listed |
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name Terminated |
IYO | None listed |
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm na Terminated |
IYO | None listed |
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor, for use with 3D Guidance medSAFE trackers, Ref. 610-1067. The firm name on the label is CIVCO, Kalona, IA. Terminated |
IYO | None listed |
| Jul 6, 2012 | Civco Medical Instruments Inc CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telesco Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.