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Rhythmlink Disposable Concentric Stimulating Probe

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K132138

by Rhythmlink International, LLC

Identifiers

510(k) Number
K132138 FDA 510(k)
FDA Product Code
PDQ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 874.1820 FDA 510(k)
Regulation Number
874.1820 FDA 510(k)
Advisory Committee
Ear, Nose, Throat FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Rhythmlink Disposable Concentric Stimulating Probe is classified as a Neurosurgical Nerve Locator, designed for intraoperative neural stimulation and nerve identification. It delivers localized electrical stimulation to neural tissue, aiding surgeons in locating, identifying, and monitoring cranial motor nerves, peripheral nerves, and spinal nerve roots during surgical procedures.

This device is intended for single-patient use and is supplied sterile. It is regulated under FDA 510(k) clearance and MDR compliance, with a classification of Class II. The probe features a concentric design with handles for ergonomic handling, and its use is restricted to controlled surgical environments where precise neural stimulation is required.

Frequently asked questions

What types of nerves can the Rhythmlink Disposable Concentric Stimulating Probe help identify during surgery, and how does its design support this purpose?

The Rhythmlink Disposable Concentric Stimulating Probe is specifically designed to assist surgeons in locating, identifying, and monitoring cranial motor nerves, peripheral nerves, and spinal nerve roots during intraoperative procedures. Its concentric design delivers precise, localized electrical stimulation to neural tissue, allowing for targeted identification without affecting surrounding areas. The ergonomic handles also enable controlled manipulation, which is critical for delicate neural work in surgical environments.

Is this probe meant for repeated use across multiple patients, or is it intended for single-patient use only?

The Rhythmlink Disposable Concentric Stimulating Probe is intended for single-patient use only, as explicitly stated in its description. This ensures sterility and safety, as it is supplied sterile and designed for one-time intraoperative application in controlled surgical settings.

What regulatory pathways does this device follow, and which medical specialties are primarily associated with its use?

The Rhythmlink Disposable Concentric Stimulating Probe is regulated under FDA 510(k) clearance and MDR compliance, with a classification as Class II. Its primary medical specialty association is Ear, Nose, and Throat (ENT), though it may also be used in neurosurgical procedures involving cranial or peripheral nerves. The device’s regulatory route reflects its specialized role in neural stimulation for precise intraoperative nerve identification.

How is the probe supplied, and what should clinicians consider regarding its storage or handling before use?

The probe is supplied sterile and ready for immediate intraoperative use. Since it is designed for single-patient use, clinicians should ensure it remains in its original packaging until use to maintain sterility. Storage should follow standard sterile instrument protocols—protected from contamination, moisture, and extreme temperatures—until the procedure begins.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Disposable Stimulating Probes - Rhythmlink, Rhythmlink Disposable Concentric Stimulating Probe, Disposable Stimulating Probe by Rhythmlink International, PDF APR 1 12014 - Food and Drug Administration

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Rhythmlink International, LLC

Sources (2)

  • FDA 510(k) K132138 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026