FDA 510(k)

Disposable guides KDNG00

K-Number: K180970 · 2018-07-10

ApplicantKoelis

Decision Date2018-07-10

Product CodeITX

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Disposable guides KDNG00 is a medical device manufactured by Koelis. It received FDA 510(k) clearance on 2018-07-10 under approval number K180970. 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 Disposable guides KDNG00?

Disposable guides KDNG00 is a medical device that received FDA 510(k) clearance on 2018-07-10. It is manufactured by Koelis. The 510(k) number is K180970.

When was Disposable guides KDNG00 approved by the FDA?

Disposable guides KDNG00 received FDA 510(k) clearance on 2018-07-10, under approval number K180970.

What company makes Disposable guides KDNG00?

Disposable guides KDNG00 is manufactured by Koelis.

What is the FDA product code for Disposable guides KDNG00?

The FDA product code for Disposable guides KDNG00 is ITX.

Other Devices by Koelis

K160357TRINITY K171040Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range K170521TRINITY/3D PROSTATE SUITE

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.