510(k) K190331

Applied Medical Laparoscopic Linear Cutter by Applied Medical Resources Corporation — Product Code GDW

K190331 is an FDA 510(k) premarket notification submitted by Applied Medical Resources Corporation for the device "Applied Medical Laparoscopic Linear Cutter". The FDA issued a decision of Substantially Equivalent on November 22, 2019. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Applied Medical Resources Corporation has at least 10 other 510(k) clearances on record.