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Leksell Neuro Generator and Accessories

by Elekta Instruments, Inc.

510(k) K941823

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 NumberK941823 Date22 Mar 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  • Withdrawn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
GXD
Device Class
Class II
Regulation
21 CFR Part 882.4400
Advisory Committee
Neurology
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 Leksell Neuro Generator and Accessories is a radiofrequency lesion generator used in neurosurgical procedures. It is designed to facilitate the creation of controlled lesions within the brain.

This device is regulated under FDA 510(k) clearance K941823. It is intended for use in clinical settings by trained medical professionals.

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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 primary function of the Leksell Neuro Generator?

    The Leksell Neuro Generator and Accessories is a radiofrequency lesion generator specifically engineered for use in neurosurgical procedures to facilitate the creation of controlled lesions within the brain.

  • Who is authorized to operate this neurosurgical equipment?

    This device is intended for use exclusively in clinical settings by trained medical professionals who are qualified to perform neurosurgical procedures.

  • What is the regulatory status of this device?

    The Leksell Neuro Generator and Accessories is regulated under FDA 510(k) clearance K941823, which signifies that the device has been determined to be substantially equivalent to legally marketed predicate devices.