Balloon Electrosurgical Probes and Devices

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

510(k) Number

K943014 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Bipolar Electrosurgical Probes & Instruments

  Class II

  FDA 510(k) K922523 Active Cleared 23 Sep 1992

• 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 →

• Are these balloon electrosurgical probes meant for repeated use in multiple patients, or are they designed for single-use only?

  These devices are explicitly designed for single-use only, as stated in the description. They come in sterile packaging to ensure safety and efficacy for one surgical procedure, preventing cross-contamination or reuse risks.

• What types of surgical procedures are these balloon electrosurgical probes primarily intended for?

  The devices are specifically designed for plastic and general surgery applications, where controlled electrical energy delivery—such as tissue ablation, coagulation, or incision—is required. The balloon components help improve precision and access during these procedures.

• How are these probes regulated in the U.S., and what does the product code (GEI) signify?

  These devices are regulated under FDA 510(k) clearance with the classification GEI, which stands for *Electrosurgical Cutting and Coagulation Accessories*. The clearance (K943014) confirms they are deemed *substantially equivalent* to a legally marketed predicate device, ensuring compliance with U.S. medical device regulations.

• Do these probes come in different sizes or models, and if so, how would I determine compatibility for my procedure?

  The provided data does not specify exact sizes or models, but the balloon design suggests variability in diameter or length to accommodate different surgical needs. For precise sizing, consult the manufacturer’s catalog or technical documentation, as compatibility depends on the specific anatomical or procedural requirements of your case.

• Are these devices safe to use in environments with MRI machines, or should they be avoided?

  The data does not mention MRI safety for these balloon electrosurgical probes, meaning their compatibility with MRI environments is not confirmed. To avoid risks, verify with the manufacturer or facility protocols before use in an MRI setting.