Modification to Ghajar Guide Twist Drill

Q: What is the product code of K932402?

The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.

FDA 510(k) K932402 · Neurodynamics, Inc.

Substantially Equivalent

510(k) numberK932402

Submission

Device name: Modification to Ghajar Guide Twist Drill
Applicant: Neurodynamics, Inc.
New York, NY, US
Received: April 21, 1993
Decision date: August 5, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: HBG – Drills, Burrs, Trephines & Accessories (Manual)
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.4300
Specialty: Neurology

Other 510(k)s with product code HBG

510(k)	Device	Applicant	Decision
K252696	LegacyHBG · Traditional	Phasor Health, LLC	11/21/2025SE
K153587	Taps for Resorbable ScrewsHBG · Traditional	Synthes (USA) Products, LLC	01/18/2017SE
K162884	SpineGuard DSG Zavation Screw SystemHBG · Traditional	Spineguard S.A.	01/12/2017SE
K160129	MRII Cranial Drill and AccessoriesHBG · Special	Mri Interventions, Inc.	03/26/2016SE
K151536	SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmHBG · Special	Mri Interventions, Inc.	07/08/2015SE
K122456	Mrii Crainial DrillHBG · Traditional	Mri Interventions, Inc.	03/22/2013SE
K022712	Hand Drill, Model 11-9901-7HBG · Traditional	Medical Design, LLC	11/12/2002SE
K022370	Framelock; Framelock AccessoriesHBG · Traditional	Medtronic Xomed, Inc.	10/18/2002SE
K961113	CNS Interchangeable Bit Cranial DrillHBG · Traditional	Clinical Neuro Systems, LLC	06/05/1996SE
K915546	PS Medical Ventriculostomy KitHBG · Traditional	Pudenz-Schulte Medical Research Corp.	12/30/1991SE

More from Pudenz-Schulte Medical Research Corp.

510(k)	Device	Decision
K875205	Tri-Flow CatheterJXG · Traditional	05/31/1988SE
K875018	Ghajar Guide Twist DrillHBG · Traditional	01/28/1988SE
K875019	Ghajar Guide System for the PerforatorHBF · Traditional	01/22/1988SE

Questions and answers

When was Modification to Ghajar Guide Twist Drill cleared by the FDA?

Modification to Ghajar Guide Twist Drill (K932402) received a 510(k) decision of Substantially Equivalent on August 5, 1993, 106 days after the submission was received.

What is the product code of K932402?

The FDA product code is HBG – Drills, Burrs, Trephines & Accessories (Manual), a Class II (moderate risk) device regulated under 21 CFR 882.4300.