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Ghajar Guide Twist Drill

by Neurodynamics, Inc. 510(k)

Active United States

510(k) K875018

Overview

The Ghajar Guide Twist Drill is a manual drill, burr, and trephine accessory used in neurological procedures. It is designed to facilitate controlled drilling during cranial surgery.

This device is manufactured by Neurodynamics, Inc. and has received FDA 510(k) clearance. It is classified as a Class 2 medical device under regulation number 882.4300.

AI-generated from registry data, 24 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK875018 Date28 Jan 1988ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HBG
Device Class
Class II
Regulation
21 CFR Part 882.4300
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Other devices from Neurodynamics, Inc.

Questions

  • What is the primary use of the Ghajar Guide Twist Drill?

    The Ghajar Guide Twist Drill is a manual accessory used specifically in neurological procedures. It is designed to assist surgeons by facilitating controlled drilling during cranial surgery.

  • What is the regulatory classification of this device?

    The Ghajar Guide Twist Drill is classified as a Class 2 medical device under regulation number 882.4300. It has received FDA 510(k) clearance, which indicates it has been found substantially equivalent to legally marketed predicate devices.

  • Who is the manufacturer of the Ghajar Guide Twist Drill?

    This device is manufactured by Neurodynamics, Inc., based in New York. The company is the applicant of record for the device's FDA 510(k) clearance.