510(k) K972426

MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH by Imagyn Medical, Inc. — Product Code HIH

K972426 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH". The FDA issued a decision of Substantially Equivalent on September 23, 1997. The device falls under product code HIH (Hysteroscope (And Accessories)), a Class II device regulated under 21 CFR 884.1690. Imagyn Medical, Inc. has at least 10 other 510(k) clearances on record.