Data / Medical devices / United States / CIVCO Medical Instruments Co., Inc.

CIVCO Medical Instruments Co., Inc.: FDA-registered device maker in Coralville, IA, United States, 23 510(k) clearances

Name: CIVCO Medical Instruments Co., Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

CIVCO Medical Instruments Co., Inc. is registered with the FDA (registration 3034286426) in Coralville, IA, United States. It lists 15 device types. The FDA files 23 510(k) clearances under its listings, the newest dated December 22, 2023. 16 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3034286426
FEI number: 1937223
Address: 750 Lois Lane, Coralville, IA, United States, 52241
Owner or operator: CIVCO Medical Instruments Co., Inc. (1937223)
Roles: Manufacturer, Repackager or relabeler, Specification developer
First device listed: August 13, 1987
Registered through: 2026
Brand names listed: AccuSITE, Active Fiducial Marker, Astra TEE, Astra VR, Brachyballoon standoff, Brachystand, Brachystepper, CIV-Clear Cover and more

Devices it lists

Device	Product code	Class	Role	Source
Basin For Endoscope Reprocessing	PHT	1	Manufacturer	accessdata.fda.gov
Cabinet, Instrument, Ac-Powered, Ophthalmic	HRE	1	Manufacturer	accessdata.fda.gov
Clamp, Surgical, General & Plastic Surgery	GDJ	1	Manufacturer	accessdata.fda.gov
Endoscope Maintenance System	PUP	2	Manufacturer	accessdata.fda.gov
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid	PSW	2	Manufacturer	accessdata.fda.gov
Indicator, Physical/Chemical Sterilization Process	JOJ	2	Repackager or relabeler	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer, Specification developer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Needle, Assisted Reproduction	MQE	2	Manufacturer, Specification developer	accessdata.fda.gov
Sterilant, Medical Devices	MED	2	Repackager or relabeler	accessdata.fda.gov
System, Applicator, Radionuclide, Manual	IWJ	1	Manufacturer, Specification developer	accessdata.fda.gov
System, Applicator, Radionuclide, Remote-Controlled	JAQ	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer, Specification developer	accessdata.fda.gov
System, Nuclear Magnetic Resonance Imaging	LNH	2	Manufacturer, Specification developer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer, Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 22, 2023	K233109	TP Pivot Pro Needle Guide	ITX	Substantially Equivalent	Civco Medical Solutions	accessdata.fda.gov
November 14, 2023	K231783	VitroPRO	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
September 13, 2021	K211270	CIV-Clear cover	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
May 24, 2019	K190802	Envision ultrasound pad and cover	ITX	Substantially Equivalent	Civco Medical Solutions	accessdata.fda.gov
June 9, 2017	K163313	ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
August 5, 2016	K160806	Verza Guidance System	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
November 16, 2015	K150504	GUS ASTRA TEE Transesophageal Probe Reprocessor, GUS ASTRA VR Endovaginal/Endorectal Probe Reprocessor	PSW	Substantially Equivalent	Pci Medical, Inc.	accessdata.fda.gov
April 14, 2015	K143333	Revital-Ox RESERT Solution Test Strip	JOJ	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
January 23, 2015	K143396	omni TRAX Active Patient Tracker	IYO	Substantially Equivalent	Civco Medical Instruments CO Inc Dba Civco Medical Solutions	accessdata.fda.gov
September 17, 2013	K131161	EX3 STEPPER, CLASSIC STEPPER, MULTI-PURPOSE WORKSTATION STEPPER; MICRO-TOUCH, MICRO-TOUCH LP, MULIT-PURPOSE WORKSTATION,	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
April 12, 2010	K091022	MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT	MED	Substantially Equivalent	STERIS Corporation	accessdata.fda.gov
January 19, 2010	K093713	ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM	ITX	Substantially Equivalent	Civco Medical Instruments	accessdata.fda.gov
November 13, 2009	K092619	ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER	IYO	Substantially Equivalent	Civco	accessdata.fda.gov
January 22, 2003	K030064	ILOOK 25 NEEDLE GUIDE ATTACHMENT AND BRACKET ASSEMBLY	ITX	Substantially Equivalent	Sonosite,Inc.	accessdata.fda.gov
December 28, 2001	K013721	SYNTHETIC POLYSIOPRENE ULTRASOUND TRANSDUCER COVER	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
August 17, 1999	K992152	GENERAL PURPOSE TRANSDUCER STANDOFF, BIOPSY TRANSDUCER STANDOFF, BI-PLANE ENDOCAVITY TRANSDUCER STANDOFF	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
July 29, 1997	K972672	BRACHYSTEPPER STEPPING UNIT, BRACHYSTEPPER NEEDLE GUIDE TEMPLATE, BRACHYSTAND SUPPORT AND MANUAL ADJUSTMENT ACCESSORY	ITX	Substantially Equivalent	Barzell-Whitmore Maroon Bells, Inc.	accessdata.fda.gov
June 20, 1997	K970515	GENERAL PURPOSE LATEX TRANSDUCER COVERS	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
June 20, 1997	K970514	DISPOSABLE TRANSRECTAL/TRANSVAGINAL/ENDOCAVITY ULTRASOUND NEEDLE INSTRUMENT GUIDE	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
June 20, 1997	K970513	GENERAL PURPOSE TRANDUCER COVER	ITX	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
April 15, 1988	K875240	TRANS/V NEEDLE GUIDE	IYO	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
April 15, 1988	K875236	TRANS/P NEEDLE GUIDE	IYO	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov
April 15, 1988	K875128	TRANS/R NEEDLE GUIDE	IYO	Substantially Equivalent	CIVCO Medical Instruments Co., Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 2, 2026	98513	Class II	Ongoing	eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number	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.	accessdata.fda.gov
May 1, 2025	96814	Class II	Ongoing	BX2 Needle Guide, Part Number, 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.	accessdata.fda.gov
October 8, 2021	88906	Class II	Terminated	VirtuTRAX Instrument Navigator, Sensor with 14 Ga VirtutTRAX	There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.	accessdata.fda.gov
July 30, 2018	80656	Class II	Terminated	CIVCO Needle Guide, REF, QTY 24, STERILE EO	The assembly of the needle guides were found to be either missing adhesive or did not have adequate adhesive to hold the assembled cannula in place on the needle guide.	accessdata.fda.gov
February 23, 2018	80704	Class II	Terminated	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 provide physicians with a	A cover failed leak testing during validation testing of new needle guides from a replacement tool.	accessdata.fda.gov
October 21, 2015	72378	Class II	Terminated	CIVCO Infiniti Plus Needle Guide, Sterile Needle Guide, 12-18GA, Rx ONLY, STERILE EO. REFs,,,. Large Gauge Infiniti Plus Needle Guides, used in needle-guided (or catheter) procedures with diagnostic ultrasound transducer	Sterility of the product cannot be assured.	accessdata.fda.gov
February 26, 2015	70719	Class II	Terminated	CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telescopically-folded cover with attached (3 cm) NeoGuard tip, REF. Each cover is packaged in a Tyvek pouch with accessories of gel and fasteners. Ind	Leaks were detected in the recalled lot which may compromise the sterility of the product.	accessdata.fda.gov
August 1, 2014	68951	Class II	Terminated	CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or st	A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.	accessdata.fda.gov
October 25, 2013	66591	Class II	Terminated	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 gynecological patients	Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.	accessdata.fda.gov
May 7, 2012	61793	Class II	Terminated	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-F	The general purpose electromagnetic sensor was incorrectly calibrated causing potential variability in the projected position of the needle path with the ultrasound device.	accessdata.fda.gov
January 21, 2011	57759	Not yet classified	Terminated	CIVCO Latex Free NeoGuard Transducer Cover, Ref, Sterile (2.6 x 30cm) cover, packaged 24/box. The firm name on the label is CIVCO, Kalona, IA.	Non-sterile transducer covers were incorrectly labeled as sterile and contained incorrect temperature storage information.	accessdata.fda.gov
December 30, 2010	57543	Not yet classified	Terminated	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 and other medical proced	Systems sold before December 2009 displayed a scale of 0-40cm going from left to right, while systems after December 2009 reversed this and were displayed as 40-0cm from left to right.	accessdata.fda.gov
July 20, 2010	56285	Not yet classified	Terminated	CIVCO Surgi-Tip Transducer Cover, Ref., Sterile (20.3 x 244cm) polyethylene telescopically-folded cover with attached (6cm) NeoGuard tip. The latex-free surgi tipped covers are utilized to cover ultrasound transducers an	Polyethylene material did not have proper treatment applied during manufacturing. Untreated polyethylene material does not maintain a secure seal with the adhesive tape used to secure the tip to the cover.	accessdata.fda.gov
June 18, 2008	48463	Not yet classified	Terminated	Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONS Is an EPID-based (electr	A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.	accessdata.fda.gov
February 25, 2008	46863	Not yet classified	Terminated	MT-APSD-2.4 Type-S Thermoplastic Mask, Medical charged-particle radiation therapy system; Disposable non-sterile (43.2cm) standard perforated thermoplastic head, neck and shoulder mask (2.4mm), 1 device per package; CIVC	Mislabeled: The mask is mislabeled with the incorrect part number but the outer packaging is correct.	accessdata.fda.gov
January 16, 2008	46743	Not yet classified	Terminated	CIVCO Latex-Free Needle Guide, Sterile transrectal needle guide for use with Shimadzu UB1OR-065U transducer, Part #, packaged 1 needle guide per tyvek pouch, 20 pouches per box. The label shows the product is Mfg by CIVC	Incorrect Needle Guide- The individual pouches contained V53W Endocavity Needle guide(p/n/) instead of the Shimadzu T/R Needle guide (p/n134-054).	accessdata.fda.gov

Compare with other makers

Updated April 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.