Nerve Locator/Stimulator

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K905045 ↗

FDA Product Code

ETN

Device Class

Class II

Regulation

21 CFR Part 874.1820

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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• How is the Nerve Locator/Stimulator intended to be used in surgical settings, and what type of nerves does it target?

  The Nerve Locator/Stimulator is designed to locate and identify exposed motor nerves during surgical procedures, such as those in the ear, nose, and throat (ENT) region. It delivers controlled electrical stimulation to help surgeons pinpoint nerves safely, reducing the risk of accidental damage or severance. This is particularly useful in delicate procedures where nerve identification is critical.

• Is the Nerve Locator/Stimulator single-use or reusable, and what sterilization process is required?

  The device is reusable and must undergo proper sterilization between uses to maintain safety and functionality. Since it is classified as a reusable Class II medical device, adherence to validated sterilization protocols (e.g., autoclave, ethylene oxide, or other approved methods) is essential to prevent cross-contamination and ensure reliable performance.

• What regulatory pathway was followed for FDA clearance of this device, and when was it originally approved?

  The Nerve Locator/Stimulator received FDA 510(k) clearance under the Traditional pathway in March 1991, with the submission filed on November 8, 1990. It was determined to be *substantially equivalent* to a predicate device and is regulated under 21 CFR 874.1820, falling under the product code ETN (Electrical Stimulators, Nerve).

• Are there any known limitations regarding MRI compatibility for this device?

  The available data does not provide specific MRI safety information for the Nerve Locator/Stimulator. Clinicians should exercise caution when using or storing the device near MRI equipment, as ferromagnetic components or electrical stimulation could pose risks in magnetic fields. Always verify compatibility with your facility’s MRI protocols before use.