510(k) K881680

ACKRAD H/S PROCEDURE TRAY by Ackrad Laboratories — Product Code HIG

K881680 is an FDA 510(k) premarket notification submitted by Ackrad Laboratories for the device "ACKRAD H/S PROCEDURE TRAY". The FDA issued a decision of Substantially Equivalent (with conditions) on July 15, 1988. The device falls under product code HIG (Insufflator, Hysteroscopic), a Class II device regulated under 21 CFR 884.1700. Ackrad Laboratories has at least 10 other 510(k) clearances on record.