510(k) K103595

ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM by Acclarent, Inc. — Product Code ETD

K103595 is an FDA 510(k) premarket notification submitted by Acclarent, Inc. for the device "ACCLARENT TYMPANOSTOMY TUBE AND TYMPANOSTOMY TUBE DELIVERY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 1, 2011. The device falls under product code ETD (Tube, Tympanostomy), a Class II device regulated under 21 CFR 874.3880. Acclarent, Inc. has at least 10 other 510(k) clearances on record.