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
- 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)
Show All 34 Submissions
- 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
Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K211291
- 510(k) Type
- Traditional
- Applicant
- Fiagon GmbH
- Country
- Germany
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/19/2021
- Days to Decision
- 82 days
- Submission Type
- Summary