510(k) K190715

EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand by Interscope, Inc. — Product Code ERL

K190715 is an FDA 510(k) premarket notification submitted by Interscope, Inc. for the device "EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand". The FDA issued a decision of Substantially Equivalent on December 13, 2019. 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. Interscope, Inc. has at least 3 other 510(k) clearances on record.