510(k) K143492

OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece by Bien-Air Surgery SA — Product Code ERL

K143492 is an FDA 510(k) premarket notification submitted by Bien-Air Surgery SA for the device "OSSEOSTAP Microdrill System (control unit and handpiece), OSSEOSTAP control unit (foot pedal), OSSEOSTAP handpiece". The FDA issued a decision of Substantially Equivalent on March 4, 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. Bien-Air Surgery SA has at least 4 other 510(k) clearances on record.