Gyrus G3 System (Generator, Assessories, Somnoplasty Electrodes and Plasmacision Electrodes)

• • Terminated Z-2651-2010 FDA Unclassified (pre-2012) ·initiated 6 Aug 2010

  Lack of sterility assurance due to compromised package seals.

• • Terminated Z-0273-2009 FDA Unclassified (pre-2012) ·initiated 1 Oct 2008

  Sterility may be compromised

510(k) Number

K041285 ↗

FDA Product Code

GEI

FDA applicant

Gyrus Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Gyrus Endourology System: Axipolar Resectoscope Electrode

  Class II

  FDA 510(k) K994166 Active Cleared 27 Dec 1999

• Gyrus Open Forceps

  Class II

  FDA 510(k) K024286 Active Cleared 17 Nov 2003

• Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors

  Class II

  FDA 510(k) K031081 Active Cleared 21 May 2003

• Zip Open Forceps with Electrosurgical Cut

  Class II

  FDA 510(k) K020585 Active Cleared 13 Jul 2002

• Gyrus Plasma Skin Resurfacing System

  Class II

  FDA 510(k) K041999 Active Cleared 2 Mar 2005

• Plasmakinetic Endourology System

  Class II

  FDA 510(k) K003569 Active Cleared 19 Dec 2000

See all devices from Gyrus Medical, Ltd. →