510(k) K854238

NEEDLE W/STYLET FOR IMPLANTATION by Microvasive — Product Code GAA

K854238 is an FDA 510(k) premarket notification submitted by Microvasive for the device "NEEDLE W/STYLET FOR IMPLANTATION". The FDA issued a decision of Substantially Equivalent on November 13, 1985. The device falls under product code GAA (Needle, Aspiration And Injection, Disposable), a Class I device regulated under 21 CFR 878.4800. Microvasive has at least 10 other 510(k) clearances on record.