Gyrus Endourology System

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

510(k) Number

K990628 ↗

FDA Product Code

KNS

FDA applicant

Gyrus Medical , Ltd.

Device Class

Class II

Regulation

21 CFR Part 876.4300

Advisory Committee

Gastroenterology, Urology

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 Gyrus Endourology System used for?

  The Gyrus Endourology System is used in urological surgical procedures for the ablation or removal of soft tissue and associated hemostasis.

• Is the Gyrus Endourology System a single-use device?

  The Gyrus Endourology System is a single device with various registration numbers, but its intended use is in a clinical setting, suggesting it is not single-use.

• What regulatory clearance does the Gyrus Endourology System have?

  The Gyrus Endourology System has an FDA 510K clearance, K990628, and is classified under regulation number 876.4300.

• What are the sizes and configurations of the Gyrus Endourology System?

  The sizes and configurations of the Gyrus Endourology System are as specified by the manufacturer, Gyrus Medical, Ltd.