510(k) K990411

MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE by Karl Storz Endoscopy — Product Code HIH

K990411 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy for the device "MVM 7.5 FRENCH FLEXIBLE HYSTEROSCOPE". The FDA issued a decision of Substantially Equivalent on May 11, 1999. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Karl Storz Endoscopy has at least 10 other 510(k) clearances on record.