Porex(Tm) Eye Sphere Implant

• • Terminated Z-0712-05 FDA Unclassified (pre-2012) ·initiated 7 Mar 2005

  The product, which is a 20mm MEDPOR Sphere, was mislabeled in that the package contained 18mm MEDPOR Spheres

510(k) Number

K863943 ↗

FDA Product Code

HPZ

Device Class

Class II

Regulation

21 CFR Part 886.3320

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Porex(Tm) Malar Implant

  Not classified

  FDA 510(k) K870182 Active Cleared 24 Feb 1987

• Porex(Tm) Extra-Ocular Orbital Implant

  Class II

  FDA 510(k) K863946 Active Cleared 27 Feb 1987

• Porex(Tm) Tissue Expander

  Unclassified

  FDA 510(k) K870154 Active Cleared 24 Feb 1987

• Tls Bulb Drainage System

  Class I

  FDA 510(k) K833586 Active Cleared 30 Jan 1984

• Porex Nerve Locator

  Class II

  FDA 510(k) K872791 Active Cleared 20 Oct 1987

• Porex(Tm) Nose Prosthesis

  Class II

  FDA 510(k) K863942 Active Cleared 24 Oct 1986

See all devices from Porex Medical →