510(k) K171840

Stryker Consolidated Operating Room Equipment (CORE) 2 Console by Stryker Corporation — Product Code ERL

K171840 is an FDA 510(k) premarket notification submitted by Stryker Corporation for the device "Stryker Consolidated Operating Room Equipment (CORE) 2 Console". The FDA issued a decision of Substantially Equivalent on September 15, 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. Stryker Corporation has at least 10 other 510(k) clearances on record.