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Aaron 1200 High Frequency Electrosurgicl Generator A1200, A1200/240

by Aaron Medical Industries

510(k) K980366

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 NumberK980366 Date27 Feb 1998ClearedStatusActive

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  • Withdrawn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, 6 Oct 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 1200 High Frequency Electrosurgical Generator is a device used for low powered electrosurgical procedures including cut, blend, coagulation, fulguration and bipolar procedures. It is intended for the removal and destruction of human tissue and the coagulation of bleeders.

This device is supplied as a reusable generator and is not specified as MRI safe. It is authorized under FDA 510K clearance with product code GEI and was determined to be substantially equivalent in 1998. The device is available in models A1200 and A1200/240.

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Questions

AI-generated answers, 6 Oct 2026

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

  • What is the Aaron 1200 High Frequency Electrosurgical Generator used for?

    The Aaron 1200 is a reusable generator designed for low powered electrosurgical procedures including cut, blend, coagulation, fulguration and bipolar procedures. It is intended for the removal and destruction of human tissue and the coagulation of bleeders during surgical procedures.

  • How is the Aaron 1200 supplied and what models are available?

    The Aaron 1200 is supplied as a reusable generator and is available in two models: A1200 and A1200/240. These models offer different power options to accommodate various surgical requirements and preferences.

  • Is the Aaron 1200 MRI safe and what is its regulatory status?

    The Aaron 1200 is not specified as MRI safe. It is authorized under FDA 510K clearance with product code GEI and was determined to be substantially equivalent in 1998, making it suitable for use in clinical settings where electrosurgical procedures are performed.

  • What procedures can be performed using the Aaron 1200 Electrosurgical Generator?

    The Aaron 1200 can be used for various electrosurgical procedures including cut, blend, coagulation, fulguration and bipolar procedures. It is specifically designed for the removal and destruction of human tissue and the coagulation of bleeders during surgical interventions.