Cauterization Smoke Evacuator

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

510(k) Number

K971758 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Gastrointestinal Tubes & Accessories

  Class II

  FDA 510(k) K945618 Active Cleared 12 Oct 1995

• Background Suction Matt

  Class I

  FDA 510(k) K895727 Active Cleared 24 Oct 1989

• Vessel Occluder

  Class I

  FDA 510(k) K895726 Active Cleared 24 Oct 1989

• Stoma Measuring Device

  Class II

  FDA 510(k) K923692 Active Cleared 7 May 1993

• One Step Button(Tm)

  Class II

  FDA 510(k) K910584 Active Cleared 23 May 1991

• Vessel Loops

  Class I

  FDA 510(k) K895682 Active Cleared 24 Oct 1989

See all devices from Applied Medical Technologies →

• What is the Cauterization Smoke Evacuator used for?

  The Cauterization Smoke Evacuator is designed to create an air suction pathway during electrocauterization procedures. It removes gases, body fluids, and smoke generated by cauterization, which improves visibility for the surgeon and reduces airborne contamination in the operating room. This accessory is specifically intended to be used alongside existing electrocauterization systems to maintain a cleaner surgical environment.

• Is the Cauterization Smoke Evacuator reusable or single-use?

  The Cauterization Smoke Evacuator is supplied as a reusable medical device. Unlike disposable accessories, it is intended for repeated use in compatible electrocauterization systems, provided proper cleaning and maintenance protocols are followed. Reusability helps reduce waste and costs while ensuring consistent performance across procedures.

• Does the Cauterization Smoke Evacuator require sterilization?

  The provided data does not specify whether the Cauterization Smoke Evacuator must be sterilized before reuse. Since it is classified as a reusable device, it should be cleaned thoroughly between uses to prevent cross-contamination. Clinicians should follow manufacturer guidelines or institutional protocols for reprocessing to ensure safety and functionality. If sterility is required for a specific procedure, additional steps may be necessary.

• What types of electrocauterization systems is it compatible with?

  The Cauterization Smoke Evacuator is designed to be an add-on accessory for standard electrosurgical units. Compatibility depends on the system’s ability to integrate with suction pathways, but no specific model restrictions are mentioned in the data. Users should verify compatibility with their existing equipment before use, ensuring the device can effectively evacuate smoke and fluids during procedures.

• Is there any information about MRI safety or sterility for this device?

  The available data does not provide explicit details regarding MRI safety or sterility requirements for the Cauterization Smoke Evacuator. Since it is intended for surgical use, clinicians should assume standard precautions apply unless otherwise specified. For MRI environments, additional checks may be needed to confirm non-ferromagnetic materials and compatibility with imaging protocols. Sterility, if required, would depend on procedural needs and institutional policies.