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Nerve Locator/Monitor System Modification

by Rln Systems, Inc.

510(k) K954601

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 NumberK954601 Date22 Dec 1995ClearedStatusActive

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  • Withdrawn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
ETN
Device Class
Class II
Regulation
21 CFR Part 874.1820
Advisory Committee
Ear, Nose, Throat
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 Nerve Locator/Monitor System Modification is a Stimulator, Nerve (per FDA nomenclature), designed to identify and monitor peripheral nerves during surgical procedures. It employs electrical stimulation to locate nerve pathways, reducing the risk of intraoperative nerve injury and improving procedural precision in otolaryngology and related specialties.

This system is intended for use in clinical settings by trained personnel, typically during otolaryngological surgeries. It is classified as a Class II device under FDA regulations (874.1820) and has received FDA 510(k) clearance as a modification of an existing nerve stimulator. Supplied as a reusable device, it requires proper calibration and maintenance per manufacturer guidelines to ensure accurate nerve localization.

Other devices from Rln Systems, Inc.

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 is the primary purpose of the Nerve Locator/Monitor System Modification during surgical procedures?

    The Nerve Locator/Monitor System Modification is designed to identify and monitor peripheral nerves during surgeries, particularly in otolaryngology. It uses electrical stimulation to pinpoint nerve pathways, helping surgeons reduce the risk of accidental nerve injury and improve precision in procedures.

  • Is this device intended for single-use or can it be reused in multiple procedures?

    The Nerve Locator/Monitor System Modification is supplied as a reusable device. To ensure accurate nerve localization, it requires proper calibration and maintenance as outlined by the manufacturer’s guidelines before each use.

  • What type of surgical specialties is this device primarily used in?

    This device is specifically intended for use in otolaryngology and related surgical specialties, where precise nerve identification is critical to minimize intraoperative complications.

  • How is the regulatory status of this device determined?

    The Nerve Locator/Monitor System Modification is classified as a Class II device under FDA regulations (874.1820) and received FDA 510(k) clearance as a modification of an existing nerve stimulator. This means it was deemed substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.

  • What should clinicians consider when storing or maintaining this reusable device?

    Since this is a reusable device, clinicians must follow the manufacturer’s instructions for proper calibration, cleaning, and maintenance to ensure its accuracy and reliability. Regular upkeep is essential to sustain performance for repeated use in surgical settings.