Sedasys Computer-Assisted Personalized Sedation System

• • Terminated Z-2374-2015 FDA Class I ·initiated 13 May 2015

  Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.

Generic Name

Computer-assisted personalized sedation system

PMA Number

P080009 ↗

FDA Product Code

PDR

Device Class

Class III

Advisory Committee

Anesthesiology

FDA Decision

APWD Approval withdrawn

• Selecticult-Chlamydia

  Class I

  FDA 510(k) K852869 Active Cleared 19 Sep 1985

• Identicult-Ae

  Class I

  FDA 510(k) K852666 Active Cleared 15 Jul 1985

• Anaswab

  Class I

  FDA 510(k) K780159 Active Cleared 13 Feb 1978

• Improved Thayer Martin Medium

  Class II

  FDA 510(k) K760598 Active Cleared 8 Oct 1976

• B. Cat Confirm

  Class I

  FDA 510(k) K880694 Active Cleared 16 Jun 1988

• Microbiological Culture Medium

  Class I

  FDA 510(k) K771936 Active Cleared 6 Dec 1977

See all devices from Scott Laboratories, Inc. →