Aerial Prosthesis, Aerial Prosthesis, Model Dusseldorf, Dresden Aerial Prosthesis, Aerial Prosthesis, Model Tubingen

No FDA recalls on record, checked 9 Oct 2026.

510(k) Number

K972585 ↗

FDA Product Code

ETA

Models / Variants

Dusseldorf

Dresden Aerial Prosthesis

Aerial Prosthesis

Model Tubingen

Device Class

Class II

Regulation

21 CFR Part 874.3495

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Kurz Upper Eyelid Implant- Platinum/Iridium, Models Regular 4007 003-007, Special 4007 002, 4007 008-010

  Class II

  FDA 510(k) K011115 Active Cleared 2 May 2001

• Clip Piston Awengen, Model# 1006 805 - 1006 861

  Class II

  CE/MDD FDA 510(k) K021479 Active Cleared 21 May 2002

• Nitiflex Stapes Prosthesis

  Class II

  CE/MDD FDA 510(k) K130512 Active Cleared 2 Dec 2013

• Trocar Ventilation Tube/with Trocar Tip, Trocar Handle, Model 1015 074, 1015 076, 1015 075, 1015 077, W/ Retention Wire

  Class II

  CE/MDD FDA 510(k) K071150 Active Cleared 12 Dec 2007

• Kurz Pure Gold Upper Eyelids Implant (Oberascher), Model 4001 02-4001 10

  Class II

  FDA 510(k) K000127 Active Cleared 12 Apr 2000

• Tubingen Tympanic Ventilation Tube, Tympanic Ventilation Tubes with Ene/S, Diabolo Tympanic Ventilation Tube, Minimal T)

  Class II

  FDA 510(k) K973226 Active Cleared 4 Nov 1997

See all devices from Heinz Kurz GmbH Medizintechnik →