510(k) K260114

Align® Cover and Pad Guidance Tool by CIVCO Medical Instruments Co., Inc. — Product Code ITX

K260114 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "Align® Cover and Pad Guidance Tool". The FDA issued a decision of Substantially Equivalent on Sep 24, 2026. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. CIVCO Medical Instruments Co., Inc. has 29 other 510(k) clearances on record.