UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece

About This 510(k) Submission

K200318 is an FDA 510(k) clearance for the UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece, a Drill, Surgical, Ent (electric Or Pneumatic) Including Handpiece (Class II — Special Controls, product code ERL), submitted by KARL STORZ Endoscopy-America, Inc. (Los Angeles, US). The FDA issued a Cleared decision on October 22, 2020, 258 days after receiving the submission on February 7, 2020. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4250.