510(k) K131053

ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM by The Anspach Effort, Inc. — Product Code ERL

K131053 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "ANSPACH XMAX, EMAX2 AND EMAX2 PLUS SYSTEM WITH OTOLOGIC ATTACHMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on December 31, 2013. 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. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.