FDA product code PGW

Ear, Nose, And Throat Stereotaxic Instrument

Neurology·Class 2·21 CFR 882.4560
US regulatory classifications
US Product Code (FDA)
PGW
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 882.4560
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Medical specialty
Neurology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

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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About this record

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.