Company · US
CIVCO Medical Instruments Co., Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2026. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (1 in 12 months)
53recalls (8 in 12 months)
51recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | 44 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 24 |
| IYE | Accelerator, Linear, Medical | 5 |
| IXQ | Table, Radiographic, Stationary Top | 3 |
| DWO | Needle, Biopsy, Cardiovascular | 1 |
| DWZ | Device, Biopsy, Endomyocardial | 1 |
| FCY | Bulb, Inflation, For Endoscope | 1 |
| FZX | Guide, Surgical, Instrument | 1 |
| GDM | Needle, Aspiration And Injection, Reusable | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KNW | Instrument, Biopsy | 1 |
| KQT | Evacuator, Gastro-Urology | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 24, 2026 | K260114 | Align® Cover and Pad Guidance Tool CIVCO Medical Instruments Co., Inc. | ITX |
| Nov 14, 2023 | K231783 | VitroPRO CIVCO Medical Instruments Co., Inc. | ITX |
| Nov 22, 2022 | K222052 | VitroPRO CIVCO Medical Instruments Co., Inc. | ITX |
| Sep 13, 2021 | K211270 | CIV-Clear cover CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 9, 2017 | K163313 | ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor CIVCO Medical Instruments Co., Inc. | ITX |
| Aug 5, 2016 | K160806 | Verza Guidance System CIVCO Medical Instruments Co., Inc. | ITX |
| Sep 17, 2013 | K131161 | EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION, CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 11, 2013 | K131528 | NON-PYROGENIC ULTRASOUND TRANSDUCER COVER CIVCO Medical Instruments Co., Inc. | ITX |
| Jan 19, 2010 | K093713 | ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM Civco Medical Instruments | ITX |
| Jun 4, 2008 | K080072 | MRI PATIENT POSITIONING DEVICES CIVCO Medical Instruments Co., Inc. | IYE |
| Dec 28, 2001 | K013721 | SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER CIVCO Medical Instruments Co., Inc. | ITX |
| Oct 31, 2000 | K002546 | CIV-FLEX HOLSTER COVER, MODEL STERILE, LATEX-FREE CIVCO Medical Instruments Co., Inc. | KNW |
| Aug 17, 1999 | K992152 | GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 2, 1999 | K991236 | GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER, SURGI-TIP INTRAOPERATIVE TRANSDUCER COVER, CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 20, 1997 | K970515 | GENERAL PURPOSE LATEX TRANSDUCER COVERS CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 20, 1997 | K970514 | DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE CIVCO Medical Instruments Co., Inc. | ITX |
| Jun 20, 1997 | K970513 | GENERAL PURPOSE TRANDUCER COVER CIVCO Medical Instruments Co., Inc. | ITX |
| Feb 2, 1995 | K943393 | CIVCO PROBE BOOT/CORD COVER CIVCO Medical Instruments Co., Inc. | KKX |
| Jun 11, 1990 | K900016 | TRANS/R - FP(3) CIVCO Medical Instruments Co., Inc. | FCY |
| Dec 14, 1989 | K895614 | CIVCO LATEX ULTRASOUND SHEATHS CIVCO Medical Instruments Co., Inc. | IYO |
| Nov 28, 1988 | K882383 | MAGGI SERIES ULTRA. NEEDLE, BIOPSY/CATHETER GUIDES CIVCO Medical Instruments Co., Inc. | DWZ |
| Apr 15, 1988 | K875240 | TRANS/V NEEDLE GUIDE CIVCO Medical Instruments Co., Inc. | IYO |
| Apr 15, 1988 | K875236 | TRANS/P NEEDLE GUIDE CIVCO Medical Instruments Co., Inc. | IYO |
| Apr 15, 1988 | K875128 | TRANS/R NEEDLE GUIDE CIVCO Medical Instruments Co., Inc. | IYO |
| Apr 14, 1988 | K875241 | CIVCO SEED IMPLANT NEEDLE GUIDE CIVCO Medical Instruments Co., Inc. | IYO |
| Jul 14, 1987 | K871413 | CIVCO STEPPER CIVCO Medical Instruments Co., Inc. | FZX |
| Jul 23, 1986 | K862481 | CIVCO/KEMPF ASPIRATION/BIOPSY/DIALYSIS NEEDLE CIVCO Medical Instruments Co., Inc. | GDM |
| Jan 23, 1985 | K844472 | CIVCO SCAN DRAPE CIVCO Medical Instruments Co., Inc. | IYO |
| Dec 13, 1984 | K843573 | CIVCO-SUPER SCAN/BIOPSY GUIDE CIVCO Medical Instruments Co., Inc. | ITX |
| May 9, 1984 | K841332 | CIVCO/SUPER SCAN CIVCO Medical Instruments Co., Inc. | IYO |
| Mar 23, 1982 | K820269 | RNG SERIES ULTRASOUND NEEDLE/CATH. GDS CIVCO Medical Instruments Co., Inc. | DWO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150 Open, Classified |
IYO | K092619 |
| Apr 1, 2026 | Civco Medical Instruments Co. Inc. eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149 Open, Classified |
IYO | K092619 |
| May 30, 2025 | Civco Medical Instruments Co. Inc. BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers Open, Classified |
ITX | K093713 |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, 10 17 GA VirtuTRAX Terminated |
IYO | K092619 |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, Sensor with 10 17 GA
VirtutTRAX Terminated |
IYO | K092619 |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX Terminated |
IYO | K092619 |
| Oct 8, 2021 | Civco Medical Instruments Co. Inc. VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX Terminated |
IYO | K092619 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Sales Demo Kit, REF DEMOGPGUIDE, for use by CIVCO and customer sales representatives. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF 674-057-10, Reusable non-sterile bracket for use with FUJIFILM SonoSite, Inc. L25 series tranducers, Rx. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF 674-057, Reusable non-sterile bracket for use with SonoSite L25 series tranducers, Rx. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. 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 transd Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. 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 transdu Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. 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 seri Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. 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 wi Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. 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 wi Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. 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 (( Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. SonoSite FUJIFILM Needle Guide Bracket, REF number P06013-08, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Mfg for: Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. SonoSite Needle Guide Bracket, REF numbers P06013-06 and P06013-07, Reusable non-sterile bracket for use with SonoSite L25 series transducers. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Biopsy Bracket, REF P03122-07, Reusable non-sterile single-angle bracket for use with SonoSite L25 series transducers. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF P03122-06, Reusable non-sterile bracket for use with SonoSite L25/L25e transducers, Mfg by: CIVCO, Kalona, IA. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. SonoSite L25 Bracket Kit containing 1 Reusable non-sterile bracket, REF numbers P03122-01, P03122-02, P03122-03, P03122-04, and P03122-05, Mfg for: SonoSite, Inc., Bothell, WA. Terminated |
ITX | K030064 |
| Nov 2, 2018 | CIVCO Medical Instruments Co., Inc. CIVCO Needle Guide Bracket, REF numbers M001457100, P06013-10, and P03122-08, reusable non-sterile single-angle bracket for use with SonoSite L25 series tranducers, RX. The firm name on the label is Terminated |
ITX | K030064 |
| Jul 30, 2018 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide, REF 676-150, QTY 24, STERILE EO Terminated |
ITX | K970514 |
| Jul 30, 2018 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide, REF 676-144, QTY 24, STERILE EO Terminated |
ITX | K970514 |
| Feb 23, 2018 | Civco Medical Instruments Co. Inc. CIVCO lnfiniti Needle Guide Bracket. used for performing needle-guided (or catheter) procedures with the use of diagnostic ultrasound transducers.
Product Usage:
The bracket and disposable guide pro Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Sales Demo Kit. REF DEMOGPGUIDE Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducers. Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Tracking Bracket Starter Kit, Reusable non-sterile PercuNav tracking bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REF 667-132. Large Gauge Infiniti Plus Needle Gui Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Biopsy Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 10787043, 11001906, 11001906(CMI), 613-247, 613-247(CMI), 620-116, 639-014, 6 Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Needle Guide Starter Kit, Reusable non-sterile bracket with Infiniti Plus (12, 14, 16, 18GA) needle guides, Rx ONLY. REFs 674-030, 674-030-T, 674-031, 674-031-T, 674-035, 674-036, 674-044, Terminated |
ITX | K093713 |
| Nov 17, 2015 | Civco Medical Instruments Co. Inc. CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs 610-1215, 610-1234, 610-1235, 610-1236. Large Gauge Infiniti Plus Needle Guides, used in needle-guided Terminated |
ITX | K093713 |
| Apr 8, 2015 | Civco Medical Instruments Inc CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF 610-833. Each cover is packaged in a Tyvek pouch with accessor Terminated |
ITX | K013721 |
| Aug 28, 2014 | Civco Medical Instruments Inc CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO.
The product is intended to be used to perform irrigation, Terminated |
KQT | None listed |
| Jan 21, 2014 | Civco Medical Instruments Inc Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box.
Product Usage: This device is intended to reduce the irradiated small bowel volume Terminated |
IYE | K121545 |
| Jan 21, 2014 | Civco Medical Instruments Inc Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box.
Product Usage: This device is intended to reduce the irradiated small bowel volume of Terminated |
IYE | K121545 |
| 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 | K092619 |
| 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 | K092619 |
| 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 | K092619 |
| 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 | K092619 |
| 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 | K092619 |
| Aug 15, 2011 | Civco Medical Instruments Inc CIVCO SBRT System, REF MTSBRT001L, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Product Usage: The recalled product is intended to support and a Terminated |
IXQ | K973842 |
| Aug 15, 2011 | Civco Medical Instruments Inc CIVCO SBRT System, REF MTSBRT001, containing CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Product Usage: The recalled product is intended to support and ai Terminated |
IXQ | K973842 |
| Aug 15, 2011 | Civco Medical Instruments Inc CIVCO Pro-Lok Platform, REF MTSBRT002. Firm name on label is CIVCO, Orange City, Iowa
Product Usage: The recalled product is intended to support and aid in positioning a patient during radiologic Terminated |
IXQ | K973842 |
| Mar 8, 2011 | Civco Medical Instruments Inc CIVCO Latex Free NeoGuard Transducer Cover, Ref 676-117, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA. Terminated |
ITX | K013721 |
| Aug 20, 2010 | Civco Medical Instruments Inc CIVCO Surgi-Tip Transducer Cover, Ref. 610-834, Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cov Terminated |
ITX | K013721 |
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