510(k) K171040

Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range by Koelis — Product Code ITX

K171040 is an FDA 510(k) premarket notification submitted by Koelis for the device "Reusable guides ranges (PERINE range, NAIL range, CON-LEAD range and LIN-LEAD range) and STEADY PRO range". The FDA issued a decision of Substantially Equivalent on Jul 31, 2017. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Koelis has 6 other 510(k) clearances on record.