Daum NeuroGate Trocar

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K990782 ↗

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 NeuroGate Trocar used for?

  The Daum NeuroGate Trocar is designed to create a controlled pathway through the skull for minimally invasive neurosurgical procedures. It allows precise insertion and fixation of neurosurgical needles and instruments, enabling diagnostic or therapeutic interventions within the cranial cavity. Its primary purpose is to facilitate safer, targeted access during neurosurgery by providing a stable channel for specialized tools.

• Is the Daum NeuroGate Trocar single-use or reusable?

  The Daum NeuroGate Trocar is a reusable surgical instrument. It is constructed from titanium and must be sterilized and maintained according to the manufacturer’s guidelines to ensure safe, repeated use in clinical settings. Reusability helps reduce waste and costs while maintaining high standards of hygiene.

• What needle sizes does the Daum NeuroGate Trocar accommodate?

  The NeuroGate Trocar is engineered to work with interchangeable channel diameters that fit Daum neuro needles of 11G, 14G, and 16G sizes. This versatility allows clinicians to select the appropriate needle gauge for their specific procedure, ensuring compatibility with the trocar’s design.

• How is the Daum NeuroGate Trocar sterilized?

  Since the NeuroGate Trocar is reusable, it must undergo proper sterilization following manufacturer guidelines to prevent contamination and ensure safety. While the regulatory data does not specify a particular sterilization method, standard practices for reusable surgical instruments—such as autoclaving or chemical sterilization—are typically used. Always follow the manufacturer’s instructions for optimal performance and longevity.

• What regulatory approval does the Daum NeuroGate Trocar hold?

  The Daum NeuroGate Trocar holds FDA 510(k) clearance under the Traditional pathway, classified as a Class II device. It was granted clearance in 1999 under the Substantially Equivalent (SESE) determination, meaning it was deemed equivalent to a legally marketed predicate device. This approval allows it to be marketed and used in clinical settings as described.