510(k) K231666

Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L) by FUJIFILM Healthcare Americas Corporation — Product Code ITX

K231666 is an FDA 510(k) premarket notification submitted by FUJIFILM Healthcare Americas Corporation for the device "Endoscopic Ultrasonic Probe (P2612S-L); Endoscopic Ultrasonic Probe (P2620S-L)". The FDA issued a decision of Substantially Equivalent on December 13, 2023. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. FUJIFILM Healthcare Americas Corporation has at least 10 other 510(k) clearances on record.