510(k) K970492

INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER by Ackrad Laboratories — Product Code LKF

K970492 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "INTRAUTERINE INSEMINATION AND SONOHYSTEROGRAPHY CATHETER". The FDA issued a decision of Substantially Equivalent on April 9, 1997. The device falls under product code LKF (Cannula, Manipulator/Injector, Uterine), a Class II device regulated under 21 CFR 884.4530. Ackrad Laboratories has at least 10 other 510(k) clearances on record.