mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more— 510(k) K260720

Name: FDA 510(k) clearance K260720
Creator: U.S. Food and Drug Administration
Published: 2026-04-03

Substantially Equivalent

MED-EL Elektromedizinische Geräte GmbH

FDA 510(k) clearance K260720 for mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more, Substantially Equivalent on 2026-04-03. Applicant: MED-EL Elektromedizinische Geräte GmbH. Device class: 2.

Summary

MED-EL Elektromedizinische Geräte's record lists ten mWING Stapes Prosthesis entries, each with its own number: nine marked 0.4 x, from 3.50 mm to 5.50 mm, and one marked 0.5 x 3.50 mm. All are filed under product code ETB (Prosthesis, Partial Ossicular Replacement).

Class II, 21 CFR 874.3450. Ear, Nose, and Throat is both the classification panel and the review panel. It came in as a Special 510(k).

MED-EL filed from Innsbruck, Austria. The record shows 29 calendar days from receipt to decision (March 5 to April 3, 2026).

Clearance details

Device name as filed: mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm) (58719); mWING Stapes Prosthesis (0.4 x 4.00 mm) (58721); mWING Stapes Prosthesis (0.4 x 4.25 mm) (58723); mWING Stapes Prosthesis (0.4 x 4.50 mm) (58725); mWING Stapes Prosthesis (0.4 x 4.75 mm) (58727); mWING Stapes Prosthesis (0.4 x 5.00 mm) (58729); mWING Stapes Prosthesis (0.4 x 5.25 mm) (58731); mWING Stapes Prosthesis (0.4 x 5.50 mm) (58733); mWING Stapes Prosthesis (0.5 x 3.50 mm) (58735);
Applicant: MED-EL Elektromedizinische Geräte GmbH
Product code: Product code ETB
Device class: Class 2
Regulation: 21 CFR 874.3450
Advisory panel: Ear, Nose, Throat
Date received: 2026-03-05
Decision date: 2026-04-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Innsbruck, AT

mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more— 510(k) K260720

Summary

Clearance details

Recent devices under product code ETB

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