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FDA 510(k)

CIV-Clear cover

K-Number: K211270 · 2021-09-13

ApplicantCIVCO Medical Instruments Co., Inc.
Decision Date2021-09-13
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CIV-Clear cover is a medical device manufactured by CIVCO Medical Instruments Co., Inc.. It received FDA 510(k) clearance on 2021-09-13 under approval number K211270. 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 CIV-Clear cover?

CIV-Clear cover is a medical device that received FDA 510(k) clearance on 2021-09-13. It is manufactured by CIVCO Medical Instruments Co., Inc.. The 510(k) number is K211270.

When was CIV-Clear cover approved by the FDA?

CIV-Clear cover received FDA 510(k) clearance on 2021-09-13, under approval number K211270.

What company makes CIV-Clear cover?

CIV-Clear cover is manufactured by CIVCO Medical Instruments Co., Inc..

What is the FDA product code for CIV-Clear cover?

The FDA product code for CIV-Clear cover is ITX.

Related Clinical Trials

NCT07071935 A Clinical Trial of Early Ventilation in Amyotrophic Lateral Sclerosis (EVENT ALS) NOT_YET_RECRUITING

Other Devices by CIVCO Medical Instruments Co., Inc.

K160806Verza Guidance System K163313ASTRA TEE Transesophageal Probe Reprocessor, ASTRA VR Endovaginal/Endorectal Probe Reprocessor K222052VitroPRO K231783VitroPRO

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

View on FDA Database →

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

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