510(k) K241261

mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit by MED-EL Elektromedizinische Geräte GmbH — Product Code ETB

K241261 is an FDA 510(k) premarket notification submitted by MED-EL Elektromedizinische Geräte GmbH for the device "mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit". The FDA issued a decision of Substantially Equivalent on January 17, 2025. The device falls under product code ETB (Prosthesis, Partial Ossicular Replacement), a Class II device regulated under 21 CFR 874.3450. MED-EL Elektromedizinische Geräte GmbH has at least 5 other 510(k) clearances on record.