CIVCO Medical Instruments Co., Inc.
Registration 3034286426FEI 1937223Coralville, IA
Owner/operator: CIVCO Medical Instruments Co., Inc.
- Develop Specifications But Do Not Manufacture At This Facility
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
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- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 33
- Added, last 12 months
- 2
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 33
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| PUP | CIVCO Storage SystemEndoscope Maintenance SystemAdded Mar 5, 2026 | Class 2 | 21 CFR 876.1500 | — |
| PSW | GUS ASTRA TEE Transesophageal Probe ReprocessorHigh Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Liquid | Class 2 | 21 CFR 892.1570 | K150504 |
| JOJ | Indicator, Physical/Chemical Sterilization ProcessGeneral Hospital | Class 2 | 21 CFR 880.2800 | K143333 |
| ILY | Thor LED CoverLamp, Infrared, Therapeutic HeatingAdded Mar 5, 2026 | Class 2 | 21 CFR 890.5500 | — |
| MQE | VitroPRONeedle, Assisted Reproduction | Class 2 | 21 CFR 884.6100 | K231783 |
| MED | Sterilant, Medical DevicesGeneral Hospital | Class 2 | 21 CFR 880.6885 | K091022 |
| JAQ | Classic StepperSystem, Applicator, Radionuclide, Remote-Controlled | Class 2 | 21 CFR 892.5700 | K131161 |
| IYO | TRANSVAGINAL BIOPSY GUIDESystem, Imaging, Pulsed Echo, Ultrasonic | Class 2 | 21 CFR 892.1560 | K875236 |
| IYO | Active Fiducial MarkerSystem, Imaging, Pulsed Echo, Ultrasonic | Class 2 | 21 CFR 892.1560 | K092619 |
| IYO | CIVCO ENDOCAVITY ULTRASOUNDSystem, Imaging, Pulsed Echo, Ultrasonic | Class 2 | 21 CFR 892.1560 | K875240 |
| IYO | Transrectal GuideSystem, Imaging, Pulsed Echo, Ultrasonic | Class 2 | 21 CFR 892.1560 | K875128 |
| IYO | omniTRAX(TM) Active Patient TrackerSystem, Imaging, Pulsed Echo, Ultrasonic | Class 2 | 21 CFR 892.1560 | K143396 |
and 21 more on your full dossier
What changed
- Mar 5, 2026Listing added: PUP — CIVCO Storage System
- Mar 5, 2026Listing added: ILY — Thor LED Cover