Titanium Middle Ear Prostheses

• • Terminated Z-2284-2013 FDA Class II ·initiated 23 Aug 2013 ·via K002897, on the same 510(k)

  One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K002897 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Kartush Tm Patcher

  Class II

  FDA 510(k) K964484 Active Cleared 24 Jan 1997

• Pope Umbrella Tube

  Class II

  FDA 510(k) K791680 Active Cleared 13 Nov 1979

• Ventilation Tube Teflon Shepard Type

  Class II

  FDA 510(k) K781259 Active Cleared 14 Aug 1978

• Merogel Otologic Pack

  Class II

  FDA 510(k) K001148 Active Cleared 3 Jun 2000

• Ventilation Tube Sili. Sheppard Type

  Class II

  FDA 510(k) K781257 Active Cleared 14 Aug 1978

• Audiant Bone Conductor at The Ear Sound Pro

  Class II

  FDA 510(k) K872168 Active Cleared 30 Jun 1987

See all devices from Xomed, Inc. →