Cui Tissue Expander Versafil(Tm) Tissue Expander

• • Terminated Z-2104-2015 FDA Class II ·initiated 18 Jun 2015

  Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life.

510(k) Number

K865056 ↗

FDA Product Code

LCJ

Device Class

U

Advisory Committee

Unknown

FDA Decision

SESE Substantially Equivalent

• Breast Prosthesis (Non & Inflatable) Skin Expander

  Unclassified

  FDA 510(k) K865033 Active Cleared 12 Jan 1987

• Cos-Uphoff Int'l Ds-5 Drainage System

  Class I

  FDA 510(k) K802214 Active Cleared 23 Oct 1980

• Cui Nasal Septum Button

  Unclassified

  FDA 510(k) K871200 Active Cleared 15 Apr 1987

• Ds-7 Closed Wound Suction Drain System

  Class II

  FDA 510(k) K813394 Active Cleared 22 Jan 1982

• Cui Rhinoplasty Implants

  Class II

  FDA 510(k) K853945 Active Cleared 18 Oct 1985

• Cui Mammary Prothesis Sizer

  Unclassified

  FDA 510(k) K831566 Active Cleared 12 Aug 1983

See all devices from Cox-Uphuff Intl. →