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FDA 510(k)

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range

K-Number: K171040 · 2017-07-31

ApplicantKoelis
Decision Date2017-07-31
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range is a medical device manufactured by Koelis. It received FDA 510(k) clearance on 2017-07-31 under approval number K171040. 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 Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range?

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range is a medical device that received FDA 510(k) clearance on 2017-07-31. It is manufactured by Koelis. The 510(k) number is K171040.

When was Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range approved by the FDA?

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range received FDA 510(k) clearance on 2017-07-31, under approval number K171040.

What company makes Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range?

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range is manufactured by Koelis.

What is the FDA product code for Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range?

The FDA product code for Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range is ITX.

Other Devices by Koelis

K160357TRINITY K170521TRINITY/3D PROSTATE SUITE K180970Disposable guides KDNG00

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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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