510(k) K965055

IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES by Imagyn Medical, Inc. — Product Code HET

K965055 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "IMAGYN MICROLAP AND MICRO LAP-GOLD LAPAROSCOPES". The FDA issued a decision of Substantially Equivalent on March 6, 1997. 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.