Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- 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
- K220920Matreneu Percutaneous Balloon Compression Kit1Cleared 510(K)
- K940973MULLAN GANGLION MICROCOMPRESSION SET1Cleared 510(K)
- K951492RIB RESECTOR1Cleared 510(K)
- K943115AUTO SUTURE PITUITARY SPINAL RONGEUR1Cleared 510(K)
- K942969AUTO SUTURE SPINAL NERVE HOOK1Cleared 510(K)
- K942971AUTO SUTURE SPINAL DISSECTOR1Cleared 510(K)
- K942967AUTO SUTURE SPINAL CURETTE1Cleared 510(K)
- K942968AUTO SUTURE SPINAL OSTEOTOME1Cleared 510(K)
- K942970AUTO SUTURE SPINAL ELEVATOR1Cleared 510(K)
- K923723SILICONE BRAIN SPATULA SET1Cleared 510(K)
- K910226DURAL DISSECTORS1Cleared 510(K)
- K910225BONE PAD REMOVER1Cleared 510(K)
- K902850ZEPPELIN INSTRUMENTS1Cleared 510(K)
- K892546TAYLOR SPINAL RETRACTOR1Cleared 510(K)
- K882422DISPOSABLE ARACHNOID KNIFE1Cleared 510(K)
- K880278MALLEABLE PTFE COATED BRAIN SPATULAE1Cleared 510(K)
- K874962FORCEPS CLIPRACK VENTRICULAR CANNULA SAWS SPATULAS1Cleared 510(K)
- K874630RANGE OF TITANIUM NEUROSURGERY INSTRUMENTS1Cleared 510(K)
- K863416RAYLOR MINI-PROBE1Cleared 510(K)
- K863415RAYLOR BONE IMPACTORS1Cleared 510(K)
- K862331FUJITSU MALLEABLE - TIP BRAIN SPATULA1Cleared 510(K)
- K861630NEUROSURGICAL INSTURMENTS (VARIOUS)1Cleared 510(K)
- K832343DERMALAND DURAL HOOKS1Cleared 510(K)
- K822048H-H NERVE ROOT RETRACTOR1Cleared 510(K)
- K821357MODIFIED NEURO SURGERY NIBBLING FORCEPS1Cleared 510(K)
- K802726INSTRUMENTS NONSTERILE & STERILE1Cleared 510(K)
- K801760FIELD-LEE BRAIN BIOPSY NEEDLE1Cleared 510(K)
- K780579SUBCUPASS TUNNELING TOOL1Cleared 510(K)
- K780520VAS APPROXIMATOR1Cleared 510(K)
- K772389DANDY HEMOSTATIC FORCEPS1Cleared 510(K)
- K772371BAYONET SURGICAL INSTRUMENTS1Cleared 510(K)
- K772013PERCUPASS TUNNELING TOOL MODEL 34521Cleared 510(K)
- K761095VANDERBILT CURETTE1Cleared 510(K)
- K761097VANDERBILT BLADE HOLDER1Cleared 510(K)
- 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
- 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
FUJITSU MALLEABLE - TIP BRAIN SPATULA
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K862331
- 510(k) Type
- Traditional
- Applicant
- DOWNS SURGICAL LTD.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/1/1986
- Days to Decision
- 12 days