510(k) K043425

SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) by Sheathing Technologies, Inc. — Product Code ITX

K043425 is an FDA 510(k) premarket notification submitted by Sheathing Technologies, Inc. for the device "SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)". The FDA issued a decision of Substantially Equivalent on February 28, 2005. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Sheathing Technologies, Inc. has at least 6 other 510(k) clearances on record.