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510(k) K252696

Device
LEGACY
Applicant
Phasor Health, LLC
510(k) number
K252696
Product code
HBG
Decision
Substantially Equivalent (SESE)
Decision date
2025-11-21
Date received
2025-08-27
Regulation
882.4300
Classification name
Drills, Burrs, Trephines & Accessories (Manual)
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ray King
Address
8944 Kirby Dr. Houston TX US 77054 77054

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HBG#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K153587Taps for Resorbable ScrewsSynthes (USA) Products, LLC2017-01-18
K162884SpineGuard DSG Zavation Screw SystemSpineguard S.A.2017-01-12
K160129MRII Cranial Drill and AccessoriesMri Interventions, Inc.2016-03-26
K151536SmartTwist MRII Hand Drill, SmartTip MRII Drill bit Kit, 4.5mm, 6.0mmMri Interventions, Inc.2015-07-08
K122456MRII CRAINIAL DRILLMri Interventions, Inc.2013-03-22
K022712HAND DRILL, MODEL 11-9901-7Medical Design, LLC2002-11-12
K022370FRAMELOCK; FRAMELOCK ACCESSORIESMedtronic Xomed, Inc.2002-10-18
K961113CNS INTERCHANGEABLE BIT CRANIAL DRILLClinical Neuro Systems, LLC1996-06-05
K932402MODIFICATION TO GHAJAR GUIDE TWIST DRILLNeurodynamics, Inc.1993-08-05
K915546PS MEDICAL VENTRICULOSTOMY KITPudenz-Schulte Medical Research Corp.1991-12-30
K904283PS MEDICAL CRANIAL HAND DRILLPudenz-Schulte Medical Research Corp.1990-10-03
K902818MULTIPLE NONPOWERED NEUROSURGICAL INSTRUMENTRuggles Corp.1990-09-20
K892531NEUROSURGICAL DRILLS: STILLE, HUDSONZinnanti Surgical Instruments, Inc.1989-05-05
K875018GHAJAR GUIDE TWIST DRILLNeurodynamics, Inc.1988-01-28
K874952MANUAL CRANIAL DRILL, BURR, TREPHINE & ACCESSORIESSolway, Inc.1987-12-30