mGRIP Partial Prosthesis (0.75 mm) (58669) +10 more— 510(k) K260718
Substantially EquivalentMED-EL Elektromedizinische Geräte GmbH
FDA 510(k) clearance K260718 for mGRIP Partial Prosthesis (0.75 mm) (58669) +10 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 mGRIP Partial Prosthesis entries, from 0.75 mm to 3.50 mm, plus an mDISC Partial Prosthesis (58850), each with its own number. 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, and it came in as a Special 510(k).
MED-EL filed from Innsbruck, Austria. The decision came 29 calendar days after FDA received it (March 5 to April 3, 2026).
Clearance details
- Device name as filed
- mGRIP Partial Prosthesis (0.75 mm) (58669);mGRIP Partial Prosthesis (1.00 mm) (58671);mGRIP Partial Prosthesis (1.25 mm) (58673);mGRIP Partial Prosthesis (1.50 mm) (58675);mGRIP Partial Prosthesis (1.75 mm) (58677);mGRIP Partial Prosthesis (2.00 mm) (58679);mGRIP Partial Prosthesis (2.25 mm) (58681);mGRIP Partial Prosthesis (2.50 mm) (58683);mGRIP Partial Prosthesis (3.00 mm) (58685);mGRIP Partial Prosthesis (3.50 mm) (58687);mDISC Partial Prosthesis (58850)
- 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
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Innsbruck, AT
Recent devices under product code ETB
view all- K260720 — mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) +9 more
- K241142 — mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis
- K241261 — mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit
- K130512 — NITIFLEX STAPES PROSTHESIS, DETROIT PISTON, SKARZYNSKI PISTON, ROBERSON STAPES PROSTHESIS
- K112616 — NITIBOND STAPES PROSTHESIS, NITIPLAST STAPES PROSTHESIS
More clearances from MED-EL Elektromedizinische Geräte GmbH
view allData sourced from openFDA. This site is unofficial and independent of the FDA.