Omnitech Resectoscope Cutting Loop Electrode

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K981464 ↗

FDA Product Code

KNF

Device Class

Class II

Regulation

21 CFR Part 884.4160

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• Omnitech Fulgurating Electrode

  Class II

  FDA 510(k) K050454 Active Cleared 27 May 2005

• Omnitech Resectoscope Roller Electrode

  Class II

  FDA 510(k) K965093 Active Cleared 19 Mar 1997

• Resectoscope Cutting Loop Electrode

  Class II

  FDA 510(k) K964365 Active Cleared 22 Apr 1997

• Omnitech HF Resection Electrodes, Omnitech HF Vaporization Electrode

  Class II

  FDA 510(k) K151976 Active Cleared 27 Jun 2016

• Omnitech Resectoscope Roller Electrode

  Class II

  FDA 510(k) K981463 Active Cleared 17 Jul 1998

• What is the Omnitech Resectoscope Cutting Loop Electrode used for?

  This device is a surgical accessory used during urological and gynecological procedures as an electrosurgical instrument for tissue resection and coagulation, connecting to compatible electrosurgical resectoscope systems.

• Is the Omnitech Resectoscope Cutting Loop Electrode single-use or reusable?

  The device is supplied for single-use in clinical and hospital settings, meaning it should be discarded after one procedure to ensure safety and effectiveness.

• What regulatory classification does this device have?

  The Omnitech Resectoscope Cutting Loop Electrode is regulated under FDA 510(k) clearance with product code KNF, classified as a Coagulator-cutter, Endoscopic, Unipolar (and Accessories), and is intended for use in Obstetrics/Gynecology procedures.

• What procedures is this device specifically designed for?

  This device is specifically designed for use in Obstetrics/Gynecology procedures, functioning as an electrosurgical instrument for tissue resection and coagulation during urological and gynecological surgeries.