Daum NeuroPuncture Needle

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K974574 ↗

FDA Product Code

KNW

Device Class

Class II

Regulation

21 CFR Part 876.1075

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Daum MRI/Conventional Biopsy Kit

  Class II

  FDA 510(k) K991366 Active Cleared 25 Jun 1999

• Daum Double-Shoot Bisopsy Gun

  Class II

  FDA 510(k) K010037 Active Cleared 22 Mar 2001

• Daum Neurobiopsy Needle

  Class II

  FDA 510(k) K974631 Active Cleared 9 Mar 1998

• Daum Biopsygun

  Class II

  FDA 510(k) K974576 Active Cleared 6 Mar 1998

• Targogrid

  Class II

  FDA 510(k) K970037 Active Cleared 12 Mar 1997

• Daum Aspirationbiopsy Needle

  Class II

  FDA 510(k) K974575 Active Cleared 6 Mar 1998

See all devices from Daum Corp. →

• What is the Daum NeuroPuncture Needle used for?

  The Daum NeuroPuncture Needle is a surgical instrument designed for brain procedures, specifically for performing punctures, biopsies, and substrate instillation. It enables image-guided access to brain tissue during surgical settings, facilitating precise tissue sampling and delivery of substances under imaging guidance.

• Is the Daum NeuroPuncture Needle reusable or single-use?

  The Daum NeuroPuncture Needle is supplied as a reusable instrument, meaning it is intended for multiple uses after proper cleaning and sterilization between procedures. This design allows for repeated clinical use in surgical environments where the instrument undergoes reprocessing to maintain safety and functionality.

• Can the Daum NeuroPuncture Needle be used in MRI environments?

  Yes, the Daum NeuroPuncture Needle is a low-artifact instrument specifically intended for use within MRI environments. Its design minimizes interference with magnetic resonance imaging, allowing physicians to perform image-guided brain procedures while maintaining image quality and procedural accuracy.

• What regulatory pathway was used for the Daum NeuroPuncture Needle?

  The Daum NeuroPuncture Needle received FDA 510(k) clearance through the Traditional pathway, with clearance number K974574 and a decision date of March 6, 1998. This indicates it was found substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the United States.