Bipolar Electrosurgical Probes & Instruments

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

510(k) Number

K922523 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Balloon Electrosurgical Probes and Devices

  Class II

  FDA 510(k) K943014 Active Cleared 11 Mar 1996

• Infralase - Laserguide Delivery System

  Class II

  FDA 510(k) K890775 Active Cleared 21 Apr 1989

• Infralase-Laserguide Delivery System

  Class II

  FDA 510(k) K892933 Active Cleared 22 Jun 1989

• Electroprobe Single-Use Surgical Probe

  Class II

  FDA 510(k) K903812 Active Cleared 20 Sep 1990

• Electroprobe Single Use Electrosurgical Probes

  Class II

  FDA 510(k) K946377 Active Cleared 24 Mar 1995

• Microlase CO2 Laser Micromanipulator

  Class II

  FDA 510(k) K891126 Active Cleared 17 Mar 1989

See all devices from Ximed Medical Systems →

• What are the Bipolar Electrosurgical Probes & Instruments used for?

  These instruments are designed for use in general and plastic surgery procedures. They utilize bipolar electrosurgical technology to perform various surgical tasks as indicated by their classification.

• What is the regulatory status of these electrosurgical instruments?

  These devices have received FDA 510(k) clearance under the number K922523. They are classified as class 2 medical devices under regulation number 878.4400, which indicates they have been found substantially equivalent to legally marketed predicate devices.

• Which advisory committee oversees this device?

  The device is overseen by the General and Plastic Surgery advisory committee, as it is specifically intended for use within those surgical specialties.