PGW · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4560
Classification
FDA Product Code
PGW
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.4560
Review panel
EN
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.