ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER— 510(k) K092619
Substantially EquivalentCivco
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. Device class: 2.
Clearance details
- Applicant
- Civco
- Product code
- Code IYO
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Kalona, IA, US
Recent devices under product code IYO
view allMore clearances from Civco
view allAdverse events under product code IYO
product code IYO- Malfunction
- 3,339
- Total
- 3,339
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K092619
K-number listed on FDA's recall record- Z-1731-2026 — eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
- Z-1732-2026 — eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
- Z-1733-2026 — eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
- Z-1734-2026 — eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
- Z-1735-2026 — eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
- Z-1736-2026 — eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
- Z-1737-2026 — eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
- Z-1738-2026 — eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
- Z-0395-2022 — VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX
- Z-0396-2022 — VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
- Z-0397-2022 — VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX
- Z-0398-2022 — VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX
- Z-1952-2012 — 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) telescopically-folded CIV-Flex sensor covers (5), Ref. 5350925. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
- Z-1953-2012 — 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 on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
- Z-1954-2012 — 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 name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
- Z-1955-2012 — 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. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
- Z-1956-2012 — 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) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part number 410-240. The general purpose sensor within the kit is intended to provide physicians with tools for electromagnetic tracking of instruments with respect to image data. The sensors are designed to attach to custom reusable tracking bracket for leading transducers and other medical devices
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K092619.
Data sourced from openFDA. This site is unofficial and independent of the FDA.