510(k) K152641

Pi Drive Plus Motor, Extender by Stryker Corporation — Product Code ERL

K152641 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Pi Drive Plus Motor, Extender". The FDA issued a decision of Substantially Equivalent on November 20, 2015. 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. Stryker Corporation has at least 10 other 510(k) clearances on record.