510(k) K000256

CAP PORP, CAP TORP by Gyrus Ent LLC — Product Code ETB

K000256 is an FDA 510(k) premarket notification submitted by Gyrus Ent LLC for the device "CAP PORP, CAP TORP". The FDA issued a decision of Substantially Equivalent on February 11, 2000. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. Gyrus Ent LLC has at least 10 other 510(k) clearances on record.