510(k) K971255

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

K971255 is an FDA 510(k) premarket notification submitted by Imagyn Medical, Inc. for the device "IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER". The FDA issued a decision of Substantially Equivalent on April 21, 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.