510(k) K183435

Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black by Ethicon Endo-Surgery, LLC — Product Code GDW

K183435 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, LLC for the device "Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black". The FDA issued a decision of Substantially Equivalent on Feb 6, 2019. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Ethicon Endo-Surgery, LLC has 183 other 510(k) clearances on record.