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Civco Medical Instruments Co. Inc.

FDA Regulatory Profile

Summary

Total Recalls
36
510(k) Clearances
29
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1738-2026Class IIeTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159March 2, 2026
Z-1735-2026Class IIeTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156March 2, 2026
Z-1732-2026Class IIeTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150March 2, 2026
Z-1737-2026Class IIeTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158March 2, 2026
Z-1731-2026Class IIeTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149March 2, 2026
Z-1736-2026Class IIeTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157March 2, 2026
Z-1734-2026Class IIeTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152March 2, 2026
Z-1733-2026Class IIeTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151March 2, 2026
Z-1892-2025Class IIBX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures wiMay 1, 2025
Z-0398-2022Class IIVirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAXOctober 8, 2021
Z-0395-2022Class IIVirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAXOctober 8, 2021
Z-0396-2022Class IIVirtuTRAX Instrument Navigator, 14 Ga VirtuTRAXOctober 8, 2021
Z-0397-2022Class IIVirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAXOctober 8, 2021
Z-0566-2019Class IISonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket forNovember 2, 2018
Z-0567-2019Class IISonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use wNovember 2, 2018
Z-0565-2019Class IICIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSiteNovember 2, 2018
Z-0572-2019Class IICIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide November 2, 2018
Z-0576-2019Class IICIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives.November 2, 2018
Z-0571-2019Class IICIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guidesNovember 2, 2018
Z-0570-2019Class IICIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket wiNovember 2, 2018

Recent 510(k) Clearances

K-NumberDeviceDate
K231783VitroPRONovember 14, 2023
K222052VitroPRONovember 22, 2022
K211270CIV-Clear coverSeptember 13, 2021
K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorJune 9, 2017
K160806Verza Guidance SystemAugust 5, 2016
K131161EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-September 17, 2013
K131528NON-PYROGENIC ULTRASOUND TRANSDUCER COVERJune 11, 2013
K080072MRI PATIENT POSITIONING DEVICESJune 4, 2008
K013721SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVERDecember 28, 2001
K002546CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREEOctober 31, 2000
K992152GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANAugust 17, 1999
K991236GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIJune 2, 1999
K970515GENERAL PURPOSE LATEX TRANSDUCER COVERSJune 20, 1997
K970514DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDEJune 20, 1997
K970513GENERAL PURPOSE TRANDUCER COVERJune 20, 1997
K943393CIVCO PROBE BOOT/CORD COVERFebruary 2, 1995
K900016TRANS/R - FP(3)June 11, 1990
K895614CIVCO LATEX ULTRASOUND SHEATHSDecember 14, 1989
K882383MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDESNovember 28, 1988
K875128TRANS/R NEEDLE GUIDEApril 15, 1988