Laparoscopic Instrument Grounding System

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

510(k) Number

K954871 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Laparoscopic Instrument Grounding System during surgery?

  The Laparoscopic Instrument Grounding System is designed to provide a safe, low-impedance electrical pathway for current dissipation during laparoscopic procedures. This prevents potential patient injury or equipment damage by ensuring proper grounding of electrosurgical instruments, which is critical when using cutting or coagulation tools in minimally invasive surgery.

• Is this device intended for reuse, or is it meant to be used only once?

  The device is explicitly labeled for single-use only in controlled surgical environments. Reuse is not recommended or supported by the manufacturer, as it could compromise safety and functionality, particularly in maintaining the low-impedance grounding path required for electrosurgical procedures.

• How is the Laparoscopic Instrument Grounding System supplied, and what does that mean for handling?

  The device is supplied sterile from the manufacturer, which means it is pre-packaged and ready for immediate use in sterile surgical settings. This eliminates the need for additional sterilization by the facility, but proper handling—such as avoiding contamination before use—is still required to maintain sterility and performance.

• What storage conditions should be followed for this device to ensure it remains functional?

  While the exact storage instructions are not detailed in the provided data, the device’s sterile packaging and single-use nature imply it should be stored in a clean, dry environment protected from physical damage or environmental contaminants. The manufacturer’s guidelines (not specified here) should be consulted for specific storage temperature or shelf-life requirements to preserve functionality and safety.