Modified Sterilization of Drills, Burrs, Trephines

• • Terminated Z-1574-05 FDA Unclassified (pre-2012) ·initiated 1 Sep 2005 ·on shared 510(k) K900388

  Potential compromise of sterile packaging for disposable dissecting tools.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K900388 ↗

FDA Product Code

HBE

Device Class

Class II

Regulation

21 CFR Part 882.4310

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Midas Rex Drill Attachments & Twist Drills

  Class I

  FDA 510(k) K954076 Active Cleared 18 Oct 1995

• Midas Rex Motors (Midas I, II & Convertible Models)

  Class I

  FDA 510(k) K952300 Active Cleared 26 May 1995

• Midas Rex Telescoping System

  Class I

  FDA 510(k) K953433 Active Cleared 15 Sep 1995

• Midas Rex Operating Room Vise

  Not classified

  FDA 510(k) K854123 Active Cleared 13 Nov 1985

• Rotating, Fixed Footed, Fixed Shield Attachments, Dissecting Tools

  Class I

  FDA 510(k) K953432 Active Cleared 14 Sep 1995

• Midas Rex Motors, (Midas I, Midas II & Convertible Models)

  Class II

  FDA 510(k) K953434 Active Cleared 16 May 1996

See all devices from Midas Rex Pneumatic Tools, Inc. →