Anesthesiology
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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
- 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
- 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
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Instrument, Surgical, Non-Powered
- Page Type
- Product Code
- Regulation Medical Specialty
- Neurology
- Review Panel
- Neurology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 882.4535
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 882.4535 Nonpowered neurosurgical instrument
§ 882.4535 Nonpowered neurosurgical instrument.
(a) Identification. A nonpowered neurosurgical instrument is a hand instrument or an accessory to a hand instrument used during neurosurgical procedures to cut, hold, or manipulate tissue. It includes specialized chisels, osteotomes, curettes, dissectors, elevators, forceps, gouges, hooks, surgical knives, rasps, scissors, separators, spatulas, spoons, blades, blade holders, blade breakers, probes, etc.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.
[44 FR 51730, Sept. 4, 1979, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38808, July 25, 2001]