Part 882 Subpart E—Neurological Surgical Devices

FDA submissions for Part 882 Subpart E—Neurological Surgical Devices in the Neurology (NE) review panel, including product codes and regulations.

Section range: §§ 882.4030–882.4950

CFR Part: 882

Product Codes

Product CodeDevice NameRegulationClassDevices
GXMAnvil, Skull Plate882.403010
HCDCannula, Ventricular882.406013
HCACatheter, Ventricular882.4100210
NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)882.410023
PVMEndoscopic Ventricular Catheter Placement Kit882.410020
SDGBrain Intraparenchymal Infusion Cannula882.411021
HBNChair, Neurosurgical882.412514
HBOClip, Scalp882.4150210
HCIApplier, Aneurysm Clip882.4175214
HBSInstrument, Clip Forming/Cutting882.419010
NMNInstrument, Clip, Forming/Cutting, Reprocessed882.419010
HBQInstrument, Clip Removal882.420010
HBRRack, Clip882.421511
GXHDevice, Surgical, Cryogenic882.4250223
GZQInstrument, Dowel Cutting882.427521
HBGDrills, Burrs, Trephines & Accessories (Manual)882.4300217
NLODrills, Burrs, Trephines And Accessories (Manual), Reprocessed882.430020
HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)882.4305218
NLPDrills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed882.430520
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)882.4310265
NLNDrills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed882.431021
PPTCranial Surgical Planning And Instrument Guides882.431024
HBDHandpiece (Brace), Drill882.432510
HBCMotor, Drill, Electric882.4360226
HBBMotor, Drill, Pneumatic882.4370227
GXDGenerator, Lesion, Radiofrequency882.4400237
SGNHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation882.442021
HBMHeadrest, Neurosurgical882.444013
HBLHolder, Head, Neurosurgical (Skull Clamp)882.4460250
HBXInstrument, Cranioplasty Material Forming882.450010
GZXInstrument, Microsurgical882.4525113
OJGNeurological Tray882.452510
HAOInstrument, Surgical, Non-Powered882.4535134
GYKInstrument, Shunt System Implantation882.4545113
PIYStainless Steel Instrument, Shunt System Implantation882.454510
HAWNeurological Stereotaxic Instrument882.45602422
OEWTracking, Soft Tissue, Intraoperative882.456024
OJPOrthopedic Computer Controlled Surgical System882.456024
OLOOrthopedic Stereotaxic Instrument882.45602423
ONAComputer Assisted Hair Harvesting System882.456024
ONNIntraoperative Orthopedic Joint Assessment Aid882.4560216
ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri882.456024
OSEPatient Specific Manual Navigation System882.456020
OSFPatient Specific Manual Orthopedic Stereotaxic System882.456023
PGWEar, Nose, And Throat Stereotaxic Instrument882.4560236
QRISurgical Planning Software For Neurological Stereotaxic Instruments882.456021
SBFOrthopedic Augmented Reality882.4560241
SGEExtracranial Positional System For A Transcranial Magnetic Stimulation System882.456021
QLVField Generator Positioning Device882.456510
GXELeukotome882.460011
HASNeedle, Neurosurgical Suture882.465010
HBANeurosurgical Paddie882.4700224
GXIProbe, Radiofrequency Lesion882.4725266
GXJPunch, Skull882.475010
GZTRetractor, Self-Retaining, For Neurosurgery882.4800243
HAERongeur, Manual882.4840236
HADRongeur, Powered882.484523
GXLScrewdriver, Skullplate882.490010
QFXDiagnostic Neurosurgical Microscope Filter882.495025
Innolitics

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