510(k) K953360

R-MED ABDOMINAL WALL ELEVATOR by R-Med, Inc. — Product Code HET

K953360 is an FDA 510(k) premarket notification submitted by R-Med, Inc. for the device "R-MED ABDOMINAL WALL ELEVATOR". The FDA issued a decision of Substantially Equivalent on January 11, 1996. The device falls under product code HET (Laparoscope, Gynecologic (And Accessories)), a Class II device regulated under 21 CFR 884.1720. R-Med, Inc. has at least 8 other 510(k) clearances on record.