510(k) K200318

UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece by KARL STORZ Endoscopy-America, Inc. — Product Code ERL

K200318 is an FDA 510(k) premarket notification submitted by KARL STORZ Endoscopy-America, Inc. for the device "UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece". The FDA issued a decision of Substantially Equivalent on October 22, 2020. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. KARL STORZ Endoscopy-America, Inc. has at least 10 other 510(k) clearances on record.