Dantec Monopolar Lumen Electrode (13R18, 13R19)

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

Full name

Dantec Monopolar Lumen Electrode (13R18 and 13R19)

510(k) Number

K950314 ↗

FDA Product Code

GXZ

Device Class

Class II

Regulation

21 CFR Part 882.1350

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Dantec Disposable Concentric Needle

  Class II

  FDA 510(k) K931966 Active Cleared 30 Mar 1994

• Dantec Electrodes Model Dne 116, 117 & 13P02/12

  Class II

  FDA 510(k) K896874 Active Cleared 18 Jun 1990

• Cantata EMG/Evoked Response System

  Class II

  FDA 510(k) K896567 Active Cleared 16 Feb 1990

• Dantec Menuet

  Class II

  FDA 510(k) K912701 Active Cleared 9 Dec 1991

• Cavernosometry Module for Menuet

  Class II

  FDA 510(k) K923117 Active Cleared 22 Feb 1993

• Dantec Magnetic Stimulator Mag 2 (Mag 2)

  Class II

  FDA 510(k) K902607 Active Cleared 14 May 1991

See all devices from Dantec Medical, Inc. →

• What clinical procedures is the Dantec Monopolar Lumen Electrode primarily used for, and why is it designed this way?

  The Dantec Monopolar Lumen Electrode (13R18 and 13R19) is designed for subcutaneous placement to stimulate or record electrical signals, making it ideal for procedures like electromyography (EMG) and nerve conduction studies. Its needle form allows for precise, deep insertion where surface electrodes might not reach, ensuring accurate signal detection or stimulation in neurological applications.

• Are the Dantec Monopolar Lumen Electrodes reusable, or are they intended for single-use only? How should they be handled?

  These electrodes are intended for single-use only and come pre-sterilized in their packaging. Like all sterile medical devices, they must be handled using aseptic techniques—opened only in a controlled environment (e.g., sterile field) and discarded immediately after use to prevent contamination or cross-infection.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for clinicians?

  The Dantec Monopolar Lumen Electrode received FDA 510(k) clearance (K950314) under the Traditional 510(k) pathway, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined it meets the same safety and effectiveness requirements as a previously approved electrode, ensuring it complies with Class II device standards (§ 882.1350) for neurological applications.

• How should these electrodes be stored before use, and what precautions should be taken?

  The electrodes should be stored in their original, unopened sterile packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediately before use to maintain sterility. Avoid exposure to moisture or chemical contaminants, as this could compromise the electrode’s integrity.