510(k) K222460

Intraoperative Ultrasound Probe Cover by Exact Medical Manufacturing — Product Code ITX

K222460 is an FDA 510(k) premarket notification submitted by Exact Medical Manufacturing for the device "Intraoperative Ultrasound Probe Cover". The FDA issued a decision of Substantially Equivalent on May 12, 2023. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Exact Medical Manufacturing has at least 8 other 510(k) clearances on record.