510(k) K943810

IMAGYN MICROLAP INTRODUCER by Imagyn Medical, Inc. — Product Code HET

K943810 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "IMAGYN MICROLAP INTRODUCER". The FDA issued a decision of Substantially Equivalent on January 26, 1995. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. Imagyn Medical, Inc. has at least 10 other 510(k) clearances on record.