HGA — Cranioclast Class II

FDA Device Classification

FDA product code HGA covers "Cranioclast", a Class II medical device regulated under 21 CFR 884.4500. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
HGA
Device Class
Class II
Regulation Number
884.4500
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No