FDA 510(k)

VitroPRO

K-Number: K231783 · 2023-11-14

ApplicantCIVCO Medical Instruments Co., Inc.

Decision Date2023-11-14

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VitroPRO is a medical device manufactured by CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2023-11-14 under approval number K231783. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VitroPRO?

VitroPRO is a medical device that received FDA 510(k) clearance on 2023-11-14. It is manufactured by CIVCO Medical Instruments Co., Inc.. The 510(k) number is K231783.

When was VitroPRO approved by the FDA?

VitroPRO received FDA 510(k) clearance on 2023-11-14, under approval number K231783.

What company makes VitroPRO?

VitroPRO is manufactured by CIVCO Medical Instruments Co., Inc..

What is the FDA product code for VitroPRO?

The FDA product code for VitroPRO is ITX.

Other Devices by CIVCO Medical Instruments Co., Inc.

K160806Verza Guidance System K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor K211270CIV-Clear cover K222052VitroPRO

Related Devices (Code: ITX)

K152126UST-5550-R; UST-5536-R; L43KHitachi Aloka Medical America, Inc. K160806Verza Guidance SystemCIVCO Medical Instruments Co., Inc. K160414Precision Point Biopsy Needle GuideCorbin Clinical Resources, LLC K153212Sheathes Ultrasound Probe CoversSheathing Technologies, Inc. K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO rangeKoelis K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe ReprocessorCIVCO Medical Instruments Co., Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.