Product code PGW

Device name

Ear, Nose, And Throat Stereotaxic Instrument

Medical specialty

Neurology

Device class

2

Regulation number

882.4560

Review panel

EN

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

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.

Source

FDA openFDA device classification dataset