Everest Bipolar Lyons Dissecting Forceps & Gyrus Bipolar Lyons Dissecting Forceps

• • Terminated Z-1983-2013 FDA Class II ·initiated 24 Jul 2013

  On April 29, 2013 Olympus Surgical Technologies America R&D received results from an accelerated aging study conducted as part of a new market submission. The study found that one of 60 Dissector units that underwent 3 year accelerated aging failed the dye penetration test indicating that the seal on sterile packaging was compromised. The dissector products are labeled with a 3 year shelf life.

510(k) Number

K031080 ↗

FDA Product Code

GEI

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. →