510(k) K233965

UltraDrape UGPIV Barrier and Securement (34-15) by Parker Laboratories, Inc. — Product Code ITX

K233965 is an FDA 510(k) premarket notification submitted by Parker Laboratories, Inc. for the device "UltraDrape UGPIV Barrier and Securement (34-15)". The FDA issued a decision of Substantially Equivalent on August 15, 2024. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Parker Laboratories, Inc. has at least 10 other 510(k) clearances on record.