Bipolar Electrosurgical Probes and Instruments

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

510(k) Number

K945995 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Electrodes/Probes/Devices

  Class II

  FDA 510(k) K974637 Active Cleared 7 Jan 1998

• Isolated Saline Electrodes/Probes/Devices-Salinetrode

  Class II

  FDA 510(k) K981256 Active Cleared 12 May 1998

• Electrosurgical Probes and Devices-Geltx

  Class II

  FDA 510(k) K002269 Active Cleared 4 Jan 2001

• Injection Needle Probe/Device-Tunis

  Class II

  FDA 510(k) K983765 Active Cleared 11 Dec 1998

• Isolated Electrosurgical Probes and Devices-Salinetrode

  Class II

  FDA 510(k) K974484 Active Cleared 10 Feb 1998

• Injection/Aspiration Needles Probes/Devices-Tpi/Tpi Flex

  Class I

  FDA 510(k) K983200 Active Cleared 11 Dec 1998

See all devices from Ximed/Prosure/Injectx →

• What is the primary function of these electrosurgical instruments?

  These instruments are designed for use in electrosurgical procedures. They function by delivering electrical current directly through tissue using bipolar energy to perform specific surgical tasks.

• What is the regulatory status of this device?

  This device is subject to FDA 510K authorization. It was determined to be substantially equivalent to existing devices through a traditional clearance process under the K945995 submission.

• Which medical specialties are these instruments associated with?

  The device is categorized under the General and Plastic Surgery advisory committee, reflecting its intended application within these surgical fields.