Everest Bipolar Needle Electrode & Gyrus Bipolar Needle Electrode

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K031079 ↗

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. →

• What is the EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE used for?

  It is used for electrosurgical cutting and mechanical dissection of tissue during laparoscopic and general surgical procedures, enabling precise tissue manipulation with bipolar energy delivery.

• Is the EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE reusable or single-use?

  The device is supplied as a reusable device, meaning it can be cleaned, sterilized, and used multiple times according to the manufacturer's reprocessing instructions.

• What regulatory clearance does the EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE have?

  It has received FDA 510(k) clearance under submission number K031079, demonstrating substantial equivalence to a predicate device cleared under K904993, and is classified as a Class II medical device.