Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- PGWEar, Nose, And Throat Stereotaxic Instrument2Product Code
- K243053Navient Image Guided Navigation System (ENT) (955-NC-NC)2Cleared 510(K)
- K231862TruDi® Navigation System V3 (FG-2000-00)2Cleared 510(K)
- K223734ENT EM2Cleared 510(K)
- K221037TruDi Shaver Blade2Cleared 510(K)
- K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit2Cleared 510(K)
- K211291Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D2Cleared 510(K)
- K202609Instrument Clamps Electromagnetic2Cleared 510(K)
- K201174TruDi Curette2Cleared 510(K)
- K200723StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762)2Cleared 510(K)
- K193453TruDi Probe2Cleared 510(K)
- K200041FlexPointer 1.5 Single Use, FlexTube 3 Single Use2Cleared 510(K)
- K193118TGS Guidewire and updated Scopis Software2Cleared 510(K)
- K193502TGS Universal Headrest with Mounting Arm2Cleared 510(K)
- K192397TruDi Navigation System2Cleared 510(K)
- K190532TruDi NAV Wire2Cleared 510(K)
- K180948TruDi NAV Suction Instruments2Cleared 510(K)
- K173628Acclarent ENT Navigation System2Cleared 510(K)
- K171661Scopis Extended Instrument Set EM2Cleared 510(K)
- K170018StealthStationTM S8 ENT Software2Cleared 510(K)
- K163416Fiagon Navigation – PointerTube Straight and PointerTube Keat2Cleared 510(K)
- K161491Scopis Hybrid Navigation System EM2Cleared 510(K)
- K162176Fiagon Navigation System2Cleared 510(K)
- K161701CARTO ENT System2Cleared 510(K)
- K161697Acclarent NavWire Sinus Navigation Guidewire2Cleared 510(K)
- K161555KARL STORZ NAV1 Electromagnetic Navigation System2Cleared 510(K)
- K161940Guidewire 0.6 Single Use2Cleared 510(K)
- K153555EM ENT Navigated Suctions2Cleared 510(K)
- K160479PointerShell Universal, PointerShell LS2Cleared 510(K)
- K160369GuideWire2Cleared 510(K)
- K153247Fusion Compact Navigation System2Cleared 510(K)
- K150473FlexPointer 1.5 mm2Cleared 510(K)
- K141456THE FIAGON NAVIGATION - EXTENDED INSTRUMENT SET ENT, REGISTRATIONPOINTER, VENTERAPOINTER, GUIDEWIRE, POINTERSHELL2Cleared 510(K)
- K141551PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES)2Cleared 510(K)
- K133573FIAGON NAVIGATION SYSTEM2Cleared 510(K)
- K133665MALLEABLE SUCTION INSTRUMENTS2Cleared 510(K)
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—General Hospital and Personal Use Miscellaneous DevicesCFR Sub-Part
- Subpart G—Miscellaneous DevicesCFR Sub-Part
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- 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
TruDi Navigation System
- Page Type
- Cleared 510(K)
- 510(k) Number
- K192397
- 510(k) Type
- Traditional
- Applicant
- Biosense Webster
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 1/30/2020
- Days to Decision
- 149 days
- Submission Type
- Summary