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
- HASNeedle, Neurosurgical Suture1Product Code
- HAWNeurological Stereotaxic Instrument2Product Code
- HBANeurosurgical Paddie2Product Code
- HBBMotor, Drill, Pneumatic2Product Code
- K172907ELAN 4 Air Motor System2Cleared 510(K)
- K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories2Cleared 510(K)
- K150801Stryker Maestro Air Motors2Cleared 510(K)
- K101168LEGEND POWER ADAPTER MODEL: 64750002Cleared 510(K)
- K093361SYNTHES AIR PEN DRIVE (APD) SYSTEM2Cleared 510(K)
- K090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA7002Cleared 510(K)
- K061297ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM2Cleared 510(K)
- K061725STRYKER ARIA PNEUMATIC SYSTEM2Cleared 510(K)
- K042974MEDICON VIPAIR HIGH SPEED SYSTEM2Cleared 510(K)
- K041754STRYKER MAESTRO SYSTEM2Cleared 510(K)
- K040186ANSPACH MRI SAFE SURGICAL DRILL SYSTEM2Cleared 510(K)
- K023066DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)2Cleared 510(K)
- K020069MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM2Cleared 510(K)
- K013091ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM2Cleared 510(K)
- K000195CRANIAL DRILL2Cleared 510(K)
- K993851SODEM PERFORATOR DRIVE2Cleared 510(K)
- K994175MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE2Cleared 510(K)
- K991625KOMET XK-95 PERFORATOR MOTOR (MI-102)2Cleared 510(K)
- K983092TRITON HUDSON CHUCK ATTACHMENT2Cleared 510(K)
- K980686AESCULAP HILAN MOTOR SYSTEM2Cleared 510(K)
- K972289MIDAS REX MOTOR2Cleared 510(K)
- K954717SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY2Cleared 510(K)
- K962483MIDAS REX III MOTOR2Cleared 510(K)
- K960630ANSPAHC SPEED REDUCER2Cleared 510(K)
- K953434MIDAS REX MOTORS, (MIDAS I, MIDAS II & CONVERTIBLE MODELS)2Cleared 510(K)
- K895739MICROMEDICS SURGICAL DRILL SYSTEM2Cleared 510(K)
- 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
MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K994175
- 510(k) Type
- Special
- Applicant
- SODEM SYSTEMS
- Country
- Switzerland
- FDA Decision
- Substantially Equivalent
- Decision Date
- 12/21/1999
- Days to Decision
- 11 days
- Submission Type
- Statement