Product code HBG— Neurology

FDA has cleared 17 devices under product code HBG between 1986 and 2025, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20251 clearance
• 20172 clearances
• 20161 clearance
• 20151 clearance
• 20131 clearance
• 20022 clearances
• 19961 clearance
• 19931 clearance
• 19911 clearance
• 19902 clearances
• 19891 clearance
• 19881 clearance
• 19871 clearance
• 19861 clearance

• Mri Interventions, Inc.3 clearances
• Pudenz-Schulte Medical Research Corp.2 clearances
• Neurodynamics, Inc.2 clearances
• Zinnanti Surgical Instruments, Inc.1 clearance
• Synthes (USA) Products, LLC1 clearance
• Spineguard S.A.1 clearance
• Solway, Inc.1 clearance
• Ruggles Corp.1 clearance
• Phasor Health, LLC1 clearance
• Medtronic Xomed, Inc.1 clearance

• K252696 — LEGACYPhasor Health, LLC·2025-11-21
• K153587 — Taps for Resorbable ScrewsSynthes (USA) Products, LLC·2017-01-18
• K162884 — SpineGuard DSG Zavation Screw SystemSpineguard S.A.·2017-01-12
• K160129 — MRII Cranial Drill and AccessoriesMri Interventions, Inc.·2016-03-26
• K151536 — SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc.·2015-07-08
• K122456 — MRII CRAINIAL DRILLMri Interventions, Inc.·2013-03-22
• K022712 — HAND DRILL, MODEL 11-9901-7Medical Design, LLC·2002-11-12
• K022370 — FRAMELOCK; FRAMELOCK ACCESSORIESMedtronic Xomed, Inc.·2002-10-18
• K961113 — CNS INTERCHANGEABLE BIT CRANIAL DRILLClinical Neuro Systems, LLC·1996-06-05
• K932402 — MODIFICATION TO GHAJAR GUIDE TWIST DRILLNeurodynamics, Inc.·1993-08-05
• K915546 — PS MEDICAL VENTRICULOSTOMY KITPudenz-Schulte Medical Research Corp.·1991-12-30
• K904283 — PS MEDICAL CRANIAL HAND DRILLPudenz-Schulte Medical Research Corp.·1990-10-03
• K902818 — MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTRuggles Corp.·1990-09-20
• K892531 — NEUROSURGICAL DRILLS: STILLE, HUDSONZinnanti Surgical Instruments, Inc.·1989-05-05
• K875018 — GHAJAR GUIDE TWIST DRILLNeurodynamics, Inc.·1988-01-28
• K874952 — MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIESSolway, Inc.·1987-12-30
• K862160 — CAMINO HAND DRILL - MODEL 030Camino Laboratories, Inc.·1986-07-18