Ear, Nose, And Throat Stereotaxic Instrument
- US Product Code (FDA)
- PGWView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 882.4560View CFR Regulation →
- Medical specialty
- Neurology
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
Intended as an aid for precisely locating a surgical instrument within anatomical structures in either open or percutaneous procedures for any medical condition in which a reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT- or MR-based model or digitized landmarks of the anatomy.
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Ear, Nose, And Throat Stereotaxic Instrument is a medical device type in the Neurology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.