510(k) K912132

OPERAND LUBRICATING JELLY by General Medical Co. — Product Code FHX

K912132 is an FDA 510(k) premarket notification submitted by General Medical Co. for the device "OPERAND LUBRICATING JELLY". The FDA issued a decision of Substantially Equivalent on August 7, 1991. The device falls under product code FHX (Jelly, Lubricating, For Transurethral Surgical Instrument), a Class II device regulated under 21 CFR 876.1500. General Medical Co. has at least 10 other 510(k) clearances on record.