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Stimuplex Nerve Stimulator

by Burron Medical Products, Inc.

510(k) K860126

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK860126 Date28 Feb 1986ClearedStatusActive

Recalls

4 recalls · 4 ongoing · FDA

  • 4 recalls, same reason

    • Ongoing Z-2134-2024 FDA Class II initiated 17 May 2024
    • Ongoing Z-2131-2024 FDA Class II initiated 17 May 2024
    • Ongoing Z-2133-2024 FDA Class II initiated 17 May 2024
    • Ongoing Z-2132-2024 FDA Class II initiated 17 May 2024

    The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.

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  • Withdrawn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
BXN
Device Class
Class II
Regulation
21 CFR Part 868.2775
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Stimuplex Nerve Stimulator is a battery-powered nerve stimulator. It is a device used for nerve stimulation. The device is classified as a Stimulator, Nerve, Battery-Powered.

The Stimuplex Nerve Stimulator is supplied with a product code of BXN and is regulated under regulation number 868.2775. It has FDA 510(k) clearance, with a decision date of 1986-02-28 and k_number K860126. The device is used in the medical specialty of Anesthesiology.

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Questions

AI-generated answers, 23 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 is the Stimuplex Nerve Stimulator used for?

    The Stimuplex Nerve Stimulator is used for nerve stimulation in the medical specialty of Anesthesiology.

  • Is the Stimuplex Nerve Stimulator supplied sterile?

    The device data does not specify if the Stimuplex Nerve Stimulator is supplied sterile, it is classified as a Stimulator, Nerve, Battery-Powered.

  • What is the regulatory classification of the Stimuplex Nerve Stimulator?

    The Stimuplex Nerve Stimulator is regulated under regulation number 868.2775 and has FDA 510(k) clearance with a decision date of 1986-02-28.