Ligasure 5mm Blunt Tip Laparoscopic Sealer-Divider

• • Terminated Z-0954-2011 FDA Unclassified (pre-2012) ·initiated 8 Dec 2010

  During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.

510(k) Number

K092879 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Models E2502B/E2525 Reusable Handswitching Pencils

  Class II

  FDA 510(k) K914400 Active Cleared 17 Oct 1991

• Cusa System 200C, T & M Ultrasonic Surgical Aspira.

  Unclassified

  FDA 510(k) K884412 Active Cleared 2 Dec 1988

• Valleylab Procision(Tm) System

  Class II

  FDA 510(k) K945688 Active Cleared 13 Jun 1995

• Davis Bayonet Electrodes

  Class II

  FDA 510(k) K964602 Active Cleared 9 Jan 1997

• Force Gsu System Model No. Gsu-20 and Gsu-22

  Class II

  FDA 510(k) K942579 Active Cleared 21 Sep 1994

• Cusa System 200C, T, M, H Ultrasonic Aspirator

  Unclassified

  FDA 510(k) K894600 Active Cleared 19 Jan 1990

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