Cleared Traditional

mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis

K241142 · Med-El Elektromedizinische Ger?te GmbH · Ear, Nose, Throat
Jan 2025
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K241142 is an FDA 510(k) clearance for the mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis, a Prosthesis, Partial Ossicular Replacement (Class II — Special Controls, product code ETB), submitted by Med-El Elektromedizinische Ger?te GmbH (Innsbruck, AT). The FDA issued a Cleared decision on January 17, 2025, 267 days after receiving the submission on April 25, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3450.

Submission Details

510(k) Number K241142 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2024
Decision Date January 17, 2025
Days to Decision 267 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF

Device Classification

Product Code ETB — Prosthesis, Partial Ossicular Replacement
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3450

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