Gold Total and Partial, Regular and Offset, Ossicular Replacement Prostheses, Gold Total with Fountian Head, Gold Piston

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K001404 ↗

FDA Product Code

ETA

Device Class

Class II

Regulation

21 CFR Part 874.3495

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Ultrabur

  Class II

  FDA 510(k) K974174 Active Cleared 10 Mar 1998

• Causse Piston

  Class II

  FDA 510(k) K972737 Active Cleared 5 Sep 1997

• Myringotomy Tube

  Class II

  FDA 510(k) K971943 Active Cleared 23 Jul 1997

• Total Ossicular Replacement Prosthesis (Torp)

  Class II

  FDA 510(k) K972735 Active Cleared 5 Sep 1997

• HA/Gold Total and Partial, Regular and Offset Ossicular Replacement Prostheses

  Class II

  FDA 510(k) K001406 Active Cleared 8 Aug 2000

• Myringotomy Tube - Bobbin with Tab

  Class II

  FDA 510(k) K972400 Active Cleared 23 Jul 1997

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