510(k) K163247

3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider by Laurimed, LLC — Product Code ERL

K163247 is an FDA 510(k) premarket notification submitted by Laurimed, LLC for the device "3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider". The FDA issued a decision of Substantially Equivalent on March 9, 2017. 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. Laurimed, LLC has at least 7 other 510(k) clearances on record.