mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more— 510(k) K260720
Substantially EquivalentMED-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.
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
- Code ETB
- Device class
- Class 2
- Regulation
- 21 CFR 874.3450
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Innsbruck, AT
Recent devices under product code ETB
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More clearances from MED-EL Elektromedizinische Geräte GmbH
view allData sourced from openFDA. This site is unofficial and independent of the FDA.