510(k) K171561

Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload by Dextera Surgical, Inc. — Product Code GDW

K171561 is an FDA 510(k) premarket notification submitted by Dextera Surgical, Inc. for the device "Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload". The FDA issued a decision of Substantially Equivalent on Aug 28, 2017. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750.