HDE — Hook, Fibroid, Gynecological Class I

FDA Device Classification

FDA product code HDE covers "Hook, Fibroid, Gynecological", a Class I medical device regulated under 21 CFR 884.4520. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
HDE
Device Class
Class I
Regulation Number
884.4520
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No