510(k) K820269

RNG SERIES ULTRASOUND NEEDLE/CATH. GDS by CIVCO Medical Instruments Co., Inc. — Product Code DWO

K820269 is an FDA 510(k) premarket notification submitted by CIVCO Medical Instruments Co., Inc. for the device "RNG SERIES ULTRASOUND NEEDLE/CATH. GDS". The FDA issued a decision of Substantially Equivalent on March 23, 1982. The device falls under product code DWO (Needle, Biopsy, Cardiovascular), a Class I device regulated under 21 CFR 878.4800. CIVCO Medical Instruments Co., Inc. has at least 10 other 510(k) clearances on record.