510(k) K834094

AUSTIN ENDOLYMPH DISPERSMENT SHUNT by Treace Medical, Inc. — Product Code ESZ

K834094 is an FDA 510(k) premarket notification submitted by Treace Medical, Inc. for the device "AUSTIN ENDOLYMPH DISPERSMENT SHUNT". The FDA issued a decision of Substantially Equivalent on September 20, 1984. The device falls under product code ESZ (Tube, Shunt, Endolymphatic), a Class II device regulated under 21 CFR 874.3820. Treace Medical, Inc. has at least 10 other 510(k) clearances on record.