Device type

Ear, Nose, And Throat Stereotaxic Instrument

Product code PGW · Class II · 21 CFR 882.4560 · Neurology

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.

FDA classification database