PGW

Ear, Nose, And Throat Stereotaxic Instrument

Product code

PGW

Device name

Ear, Nose, And Throat Stereotaxic Instrument

Device class

Class 2

21 CFR

21 CFR 882.4560

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

3

Summaries archived here

2 (direct download)

510(k) clearances (all years, FDA)

37 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (3)

Last three years. Most recent: 2026-06-02.

2 summaries are archived here for direct download.