Civco Medical Instruments Co. Inc.
Civco Medical Instruments Co. Inc. appears in FDA public data with 36 recalls, 29 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1731-2026, Class II) was initiated on March 2, 2026. Its most recent 510(k) clearance was granted on November 14, 2023.
Summary
- Total Recalls
- 36
- 510(k) Clearances
- 29
- Inspections
- 4
- Compliance Actions
- 0
Known Names
civco medical instruments co, civco medical instruments
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1731-2026 | Class II | eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 | March 2, 2026 |
| Z-1737-2026 | Class II | eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 | March 2, 2026 |
| Z-1738-2026 | Class II | eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 | March 2, 2026 |
| Z-1736-2026 | Class II | eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 | March 2, 2026 |
| Z-1732-2026 | Class II | eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 | March 2, 2026 |
| Z-1735-2026 | Class II | eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 | March 2, 2026 |
| Z-1734-2026 | Class II | eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 | March 2, 2026 |
| Z-1733-2026 | Class II | eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 | March 2, 2026 |
| Z-1892-2025 | Class II | BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures wi | May 1, 2025 |
| Z-0398-2022 | Class II | VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX | October 8, 2021 |
| Z-0395-2022 | Class II | VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX | October 8, 2021 |
| Z-0396-2022 | Class II | VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX | October 8, 2021 |
| Z-0397-2022 | Class II | VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX | October 8, 2021 |
| Z-0566-2019 | Class II | SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for | November 2, 2018 |
| Z-0576-2019 | Class II | CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives. | November 2, 2018 |
| Z-0571-2019 | Class II | CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides | November 2, 2018 |
| Z-0570-2019 | Class II | CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket wi | November 2, 2018 |
| Z-0568-2019 | Class II | CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket w | November 2, 2018 |
| Z-0562-2019 | Class II | CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile s | November 2, 2018 |
| Z-0567-2019 | Class II | SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use w | November 2, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K231783 | VitroPRO | November 14, 2023 |
| K222052 | VitroPRO | November 22, 2022 |
| K211270 | CIV-Clear cover | September 13, 2021 |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | June 9, 2017 |
| K160806 | Verza Guidance System | August 5, 2016 |
| K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT- | September 17, 2013 |
| K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | June 11, 2013 |
| K080072 | MRI PATIENT POSITIONING DEVICES | June 4, 2008 |
| K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | December 28, 2001 |
| K002546 | CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE | October 31, 2000 |
| K992152 | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STAN | August 17, 1999 |
| K991236 | GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATI | June 2, 1999 |
| K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE | June 20, 1997 |
| K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS | June 20, 1997 |
| K970513 | GENERAL PURPOSE TRANDUCER COVER | June 20, 1997 |
| K943393 | CIVCO PROBE BOOT/CORD COVER | February 2, 1995 |
| K900016 | TRANS/R - FP(3) | June 11, 1990 |
| K895614 | CIVCO LATEX ULTRASOUND SHEATHS | December 14, 1989 |
| K882383 | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES | November 28, 1988 |
| K875240 | TRANS/V NEEDLE GUIDE | April 15, 1988 |