510(k) K853312

ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES by Argon Medical Corp. — Product Code DWO

K853312 is an FDA 510(k) premarket notification submitted by Argon Medical Corp. for the device "ARGON CUT BIOPSY NEEDLES, VARIOUS SIZES". The FDA issued a decision of Substantially Equivalent on September 12, 1985. The device falls under product code DWO (Needle, Biopsy, Cardiovascular), a Class I device regulated under 21 CFR 878.4800. Argon Medical Corp. has at least 10 other 510(k) clearances on record.