510(k) K150969

Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces by Karl Storz Endoscopy America, Inc. — Product Code ERL

K150969 is an FDA 510(k) premarket notification submitted by Karl Storz Endoscopy America, Inc. for the device "Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces". The FDA issued a decision of Substantially Equivalent on January 8, 2016. 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.