CIVCO Medical Instruments Co., Inc.
Coralville, IA, US
CIVCO Medical Instruments Co., Inc. appears in FDA device records in Coralville, IA. FDA records list 30 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 53 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 30 510(k) clearances for CIVCO Medical Instruments Co., Inc. between 1982 and 2023. The busiest year on record is 1988, with 5. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1984 | 2 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 5 |
| 1989 | 1 |
| 1990 | 1 |
| 1995 | 1 |
| 1997 | 3 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2013 | 2 |
| 2016 | 1 |
| 2017 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231783 | VitroPRO | ITX | Substantially Equivalent | |
| K222052 | VitroPRO | ITX | Substantially Equivalent | |
| K211270 | CIV-Clear cover | ITX | Substantially Equivalent | |
| K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor | ITX | Substantially Equivalent | |
| K160806 | Verza Guidance System | ITX | Substantially Equivalent | |
| K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, | ITX | Substantially Equivalent | |
| K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER | ITX | Substantially Equivalent | |
| K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM | ITX | Substantially Equivalent | |
| K080072 | MRI PATIENT POSITIONING DEVICES | IYE | Substantially Equivalent | |
| K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER | ITX | Substantially Equivalent | |
| K002546 | CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE | KNW | Substantially Equivalent | |
| K992152 | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF | ITX | Substantially Equivalent | |
| K991236 | GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, | ITX | Substantially Equivalent | |
| K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS | ITX | Substantially Equivalent | |
| K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE | ITX | Substantially Equivalent | |
| K970513 | GENERAL PURPOSE TRANDUCER COVER | ITX | Substantially Equivalent | |
| K943393 | CIVCO PROBE BOOT/CORD COVER | KKX | Substantially Equivalent | |
| K900016 | TRANS/R - FP(3) | FCY | Substantially Equivalent | |
| K895614 | CIVCO LATEX ULTRASOUND SHEATHS | IYO | Substantially Equivalent | |
| K882383 | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES | DWZ | Substantially Equivalent | |
| K875240 | TRANS/V NEEDLE GUIDE | IYO | Substantially Equivalent | |
| K875236 | TRANS/P NEEDLE GUIDE | IYO | Substantially Equivalent | |
| K875128 | TRANS/R NEEDLE GUIDE | IYO | Substantially Equivalent | |
| K875241 | CIVCO SEED IMPLANT NEEDLE GUIDE | IYO | Substantially Equivalent | |
| K871413 | CIVCO STEPPER | FZX | Substantially Equivalent | |
| K862481 | CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE | GDM | Substantially Equivalent | |
| K844472 | CIVCO SCAN DRAPE | IYO | Substantially Equivalent | |
| K843573 | CIVCO-SUPER SCAN/BIOPSY GUIDE | ITX | Substantially Equivalent | |
| K841332 | CIVCO/SUPER SCAN | IYO | Substantially Equivalent | |
| K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS | DWO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3034286426 | 1937223 | CIVCO Medical Instruments Co., Inc. | 750 Lois Lane, Coralville, IA 52241 US | 2026 | and 5 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- PHTBasin For Endoscope Reprocessing
- FCYBulb, Inflation, For Endoscope
- HRECabinet, Instrument, Ac-Powered, Ophthalmic
- GDJClamp, Surgical, General & Plastic Surgery
- DWZDevice, Biopsy, Endomyocardial
- KKXDrape, Surgical, Antimicrobial
- PUPEndoscope Maintenance System
- FZXGuide, Surgical, Instrument
- PSWHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid
- JOJIndicator, Physical/Chemical Sterilization Process
- KNWInstrument, Biopsy
- MDMInstrument, Manual, Surgical, General Use
- ILYLamp, Infrared, Therapeutic Heating
- GDMNeedle, Aspiration And Injection, Reusable
- MQENeedle, Assisted Reproduction
- DWONeedle, Biopsy, Cardiovascular
- MEDSterilant, Medical Devices
- IWJSystem, Applicator, Radionuclide, Manual
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- IYOSystem, Imaging, Pulsed Echo, Ultrasonic
- LNHSystem, Nuclear Magnetic Resonance Imaging
- ITXTransducer, Ultrasonic, Diagnostic
Recall records
Showing 25 of 53| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1738-2026 | eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Class II | Open, Classified | |
| Z-1737-2026 | eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Class II | Open, Classified | |
| Z-1736-2026 | eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Class II | Open, Classified | |
| Z-1735-2026 | eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Class II | Open, Classified | |
| Z-1734-2026 | eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Class II | Open, Classified | |
| Z-1733-2026 | eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Class II | Open, Classified | |
| Z-1732-2026 | eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Class II | Open, Classified | |
| Z-1731-2026 | eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 | There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface. | Class II | Open, Classified | |
| Z-1892-2025 | BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers | During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place. | Class II | Open, Classified | |
| Z-0398-2022 | VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Class II | Terminated | |
| Z-0397-2022 | VirtuTRAX Instrument Navigator, Sensor with 10 17 GA VirtutTRAX | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Class II | Terminated | |
| Z-0396-2022 | VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Class II | Terminated | |
| Z-0395-2022 | VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX | There is potential that the VirtuTRAX device will not tighten onto the instrument to be used. | Class II | Terminated | |
| Z-0576-2019 | CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives. | Class II | Terminated | ||
| Z-0575-2019 | CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx. | Class II | Terminated | ||
| Z-0574-2019 | CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx. | Class II | Terminated | ||
| Z-0573-2019 | CIVCO Needle Guide Starter Kit, REF 674-039, Reusable non-sterile bracket with sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 22 GAUGE, Rx. | Class II | Terminated | ||
| Z-0572-2019 | CIVCO Needle Guide Starter Kit, REF 674-038, Reusable non-sterile bracket with sterile needle guide (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 21 GAUGE, Rx. The firm name on the label is CIVCO, Kalona, IA.. | Class II | Terminated | ||
| Z-0571-2019 | CIVCO Needle Guide Starter Kit, REF 674-037, Reusable non-sterile bracket with sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5 depths) with (10.2 x 147cm) CIV-Flex cover for use with SonoSite L25 series transducers, 18 GAUGE, Rx. | Class II | Terminated | ||
| Z-0570-2019 | CIVCO Needle Guide Starter Kit, REF numbers P12924-01 and P12924-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 22 GAUGE, Rx. | Class II | Terminated | ||
| Z-0569-2019 | CIVCO Needle Guide Starter Kit, REF numbers P12922-01 and P12922-02, Reusable non-sterile bracket with sterile (1cm, 1.5cm, 2cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers (5) for use with SonoSite L25 series transducers, 21 GAUGE, Rx. | Class II | Terminated | ||
| Z-0568-2019 | CIVCO Needle Guide Starter Kit, REF numbers P12920-01 and P12920-02, Reusable non-sterile bracket with sterile (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) needle guides (5), (10.2 x 147cm) CIV-Flex covers ((5) for use with SonoSite L25 series transducers, 18 GAUGE, Rx. | Class II | Terminated | ||
| Z-0567-2019 | SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for: | Class II | Terminated | ||
| Z-0566-2019 | SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers. | Class II | Terminated | ||
| Z-0565-2019 | CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain