510(k) K963580

IMAGYN FALLOPOSCOPY SYSTEM by Imagyn Medical, Inc. — Product Code MKO

K963580 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "IMAGYN FALLOPOSCOPY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 31, 1997. The device falls under product code MKO (Falloposcope), a Class II device regulated under 21 CFR 884.1690. Imagyn Medical, Inc. has at least 10 other 510(k) clearances on record.