510(k) Report

Devices descending from K021479

8 later devices reach Clip Piston Awengen, Model# 1006 805 - 1006 861 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241142mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes…MED-EL Elektromedizinische Geräte GmbH20251—
+1K130512Nitiflex Stapes Prosthesis, Detroit Piston, Skarzynski Piston, Roberson Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20132—
+1K112616Nitibond Stapes Prosthesis, Nitiplast Stapes ProsthesisHeinz Kurz GmbH Medizintechnik20133—
+1K063374Nitinol Locking Incudo-Stapedial Joint, Angular Piston, Piston, Malleus Piston, Porp and…Grace Medical, Inc.20064—
+1K042503Kurz Clip Piston MVP, Model 1006 711-13/0.4 MM + 1006 761-63/0.6MMHeinz Kurz GmbH Medizintechnik20047—
+2K260720mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717); mWING Stapes Prosthesis (0.4 x 3.75 mm)…MED-EL Elektromedizinische Geräte GmbH20260—
+2K080070K-Helix Piston and Porp Partial Ossicular Replacement ProsthesesGrace Medical, Inc.20081—
+3K091187Grace Dynamic TorpGrace Medical, Inc.20090—