Anesthesiology
Review Panel
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- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- GXDGenerator, Lesion, Radiofrequency2Product Code
- GXELeukotome1Product Code
- GXHDevice, Surgical, Cryogenic2Product Code
- GXIProbe, Radiofrequency Lesion2Product Code
- GXJPunch, Skull1Product Code
- GXLScrewdriver, Skullplate1Product Code
- GXMAnvil, Skull Plate1Product Code
- GYKInstrument, Shunt System Implantation1Product Code
- GZQInstrument, Dowel Cutting2Product Code
- GZTRetractor, Self-Retaining, For Neurosurgery2Product Code
- GZXInstrument, Microsurgical1Product Code
- HADRongeur, Powered2Product Code
- HAERongeur, Manual2Product Code
- HAOInstrument, Surgical, Non-Powered1Product Code
- HASNeedle, Neurosurgical Suture1Product Code
- HAWNeurological Stereotaxic Instrument2Product Code
- HBANeurosurgical Paddie2Product Code
- HBBMotor, Drill, Pneumatic2Product Code
- HBCMotor, Drill, Electric2Product Code
- HBDHandpiece (Brace), Drill1Product Code
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)2Product Code
- K250815Hubly Drill (H100)2Cleared 510(K)
- K252060GREEN2Cleared 510(K)
- K252662UniBur2Cleared 510(K)
- K251433Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1); Surgify Halo (40.070.NVG.H1); Surgify Halo (40.125.NVG.H1); Surgify Halo (40.000.SEE.H1)2Cleared 510(K)
- K250380Surgify Halo (54.085.SHD.H1); Surgify Halo (54.140.SHD.H1); Surgify Halo (54.070.NVG.H1); Surgify Halo (54.125.NVG.H1); Surgify Halo (54.000.SEE.H1)2Cleared 510(K)
- K250374iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R2Cleared 510(K)
- K232684Surgify Halo2Cleared 510(K)
- K230619Hubly Electric Drill (H100)2Cleared 510(K)
- K2231992.1 x 255mm Drill, 22mm Stop2Cleared 510(K)
- K2130722.1 x 255mm Drill, 22mm Stop2Cleared 510(K)
Show All 64 Submissions
- HBFDrills, Burrs, Trephines & Accessories (Compound, Powered)2Product Code
- HBGDrills, Burrs, Trephines & Accessories (Manual)2Product Code
- HBLHolder, Head, Neurosurgical (Skull Clamp)2Product Code
- HBMHeadrest, Neurosurgical1Product Code
- HBNChair, Neurosurgical1Product Code
- HBOClip, Scalp2Product Code
- HBQInstrument, Clip Removal1Product Code
- HBRRack, Clip1Product Code
- HBSInstrument, Clip Forming/Cutting1Product Code
- HBXInstrument, Cranioplasty Material Forming1Product Code
- HCACatheter, Ventricular2Product Code
- HCDCannula, Ventricular1Product Code
- HCIApplier, Aneurysm Clip2Product Code
- NHCCatheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)2Product Code
- NLNDrills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed2Product Code
- NLODrills, Burrs, Trephines And Accessories (Manual), Reprocessed2Product Code
- NLPDrills, Burrs, Trephines, And Accessories (Powered Compound), Reprocessed2Product Code
- NMNInstrument, Clip, Forming/Cutting, Reprocessed1Product Code
- OJGNeurological Tray1Product Code
- ORRNeurological Stereotaxic Instrument, Real-Time Intraoperative Mri2Product Code
- PIYStainless Steel Instrument, Shunt System Implantation1Product Code
- PPTCranial Surgical Planning And Instrument Guides2Product Code
- PVMEndoscopic Ventricular Catheter Placement Kit2Product Code
- QFXDiagnostic Neurosurgical Microscope Filter2Product Code
- QRISurgical Planning Software For Neurological Stereotaxic Instruments2Product Code
- SGEExtracranial Positional System For A Transcranial Magnetic Stimulation System2Product Code
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
UniBur
- Page Type
- Cleared 510(K)
- 510(k) Number
- K252662
- 510(k) Type
- Traditional
- Applicant
- Nakanishi Inc.
- Country
- Japan
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/19/2025
- Days to Decision
- 28 days
- Submission Type
- Summary