510(k) K212650

Celeris, Disposable Sinus Debrider by Gyrus Acmi, Inc. — Product Code ERL

K212650 is an FDA 510(k) premarket notification submitted by Gyrus Acmi, Inc. for the device "Celeris, Disposable Sinus Debrider". The FDA issued a decision of Substantially Equivalent on January 19, 2022. 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. Gyrus Acmi, Inc. has at least 10 other 510(k) clearances on record.