Nerve Monitor Electrodes/Stimulator Probes

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

510(k) Number

K945242 ↗

FDA Product Code

ETN

Device Class

Class II

Regulation

21 CFR Part 874.1820

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Micromed Total Regular and Partial Offset

  Class II

  FDA 510(k) K945106 Active Cleared 22 Nov 1994

• Poly Piston

  Class II

  FDA 510(k) K945108 Active Cleared 22 Nov 1994

• Polyethylene Vent Tubes

  Class II

  FDA 510(k) K943281 Active Cleared 24 Aug 1994

• Edi-Bur Microdrill Systems

  Class II

  FDA 510(k) K945438 Active Cleared 22 Nov 1994

• C-Flex Vent Tubes

  Class II

  FDA 510(k) K943190 Active Cleared 24 Aug 1994

• Disposable Joint Aspiration/Injection Diagnostic Kit

  Class II

  FDA 510(k) K945831 Active Cleared 20 Jan 1995

See all devices from Micromed Development Corp. →

• What are the Micromed Nerve Monitor Electrodes/Stimulator Probes used for?

  These electrodes are designed to monitor nerve function during surgical procedures, particularly in ear, nose, and throat (ENT) surgeries. They deliver controlled electrical stimulation to assess nerve integrity and response in real time, helping surgeons prevent nerve damage and ensure precise anatomical navigation.

• Are the Nerve Monitor Electrodes/Stimulator Probes single-use or reusable?

  The devices are classified as single-use, non-sterile probes intended for use in controlled clinical environments. However, they are supplied as either reusable or disposable probes depending on the specific model reference. Always follow the manufacturer’s instructions for proper handling and use.

• Do these electrodes require special storage or handling?

  Yes, the electrodes must be stored and handled according to the manufacturer’s guidelines to maintain their functionality. Since they are single-use in some models, ensure they are kept in a clean, dry environment away from direct sunlight or extreme temperatures until use.

• Are there different sizes or models available for these nerve stimulator probes?

  Yes, the Nerve Monitor Electrodes/Stimulator Probes come in multiple sizes and models, each referenced by a unique identifier. The specific model determines compatibility with surgical procedures and electrode placement. Check the manufacturer’s documentation for details on selecting the appropriate size for your application.

• What regulatory clearance do these nerve stimulator probes hold?

  These devices hold FDA 510(k) clearance (K945242) under the classification of nerve stimulators, with substantial equivalence determined for use in nerve monitoring during ENT procedures. The clearance is specific to the intended use as described in the manufacturer’s submission.