510(k) K003840

CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES by I.C Medical, Inc. — Product Code FYD

K003840 is an FDA 510(k) premarket notification submitted by I.C Medical, Inc. for the device "CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES". The FDA issued a decision of Substantially Equivalent on February 1, 2001. The device falls under product code FYD (Apparatus, Exhaust, Surgical), a Class II device regulated under 21 CFR 878.5070. I.C Medical, Inc. has at least 10 other 510(k) clearances on record.