510(k) K180134

Ensizor Monopolar Endoscopic Scissors by Slater Endoscopy, LLC — Product Code KGE

K180134 is an FDA 510(k) premarket notification submitted by Slater Endoscopy, LLC for the device "Ensizor Monopolar Endoscopic Scissors". The FDA issued a decision of Substantially Equivalent on June 29, 2018. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Slater Endoscopy, LLC has at least 2 other 510(k) clearances on record.