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Aaron 800 High Frequency Desiccator/Handpiece

by Geiger Instrument Co., Inc.

510(k) K955681

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK955681 Date8 Feb 1996ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GEI
Device Class
Class II
Regulation
21 CFR Part 878.4400
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Aaron 800 High Frequency Desiccator/Handpiece is an electrosurgical device designed for tissue removal and hemostasis using high-frequency electrical current. It falls under the category of electrosurgical cutting and coagulation instruments, delivering precise control for surgical procedures requiring desiccation or cauterization.

This device is intended for use in surgical settings, supplied as a reusable medical instrument. It is regulated under FDA 510(k) clearance (K955681) and is classified under the General, Plastic Surgery advisory committee. No specific sterility or MRI safety information is provided in the available data.

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of surgical procedures is the Aaron 800 High Frequency Desiccator/Handpiece designed for?

    The Aaron 800 is designed for tissue removal and hemostasis (stopping bleeding) during surgical procedures. It uses high-frequency electrical current for precise desiccation (drying tissue) or cauterization (sealing blood vessels), making it suitable for general surgical applications where controlled tissue manipulation is required, such as in plastic surgery or other elective procedures.

  • Is the Aaron 800 High Frequency Desiccator/Handpiece intended for single-use or reusable applications?

    The Aaron 800 is explicitly supplied as a reusable medical instrument. Unlike disposable devices, it is meant to be cleaned, sterilized, and reused for multiple surgical procedures, though proper maintenance and sterilization protocols must be followed to ensure safety and performance.

  • How is the Aaron 800 High Frequency Desiccator/Handpiece regulated in the U.S.?

    The device is regulated under the FDA 510(k) clearance process, with clearance number K955681. It was determined to be substantially equivalent to a legally marketed predicate device and falls under the General, Plastic Surgery advisory committee category. This means it underwent review by the FDA to ensure compliance with safety and performance standards before market authorization.

  • Does the Aaron 800 come with any specific storage or handling instructions?

    The provided data does not include explicit storage instructions, but as a reusable electrosurgical instrument, it should be stored in a clean, dry environment to prevent contamination or damage. Proper maintenance, including cleaning and sterilization between uses, is critical to ensure functionality and patient safety. Always follow manufacturer guidelines for handling and storage.