HEC — Insufflator, Vaginal Class I

FDA Device Classification

FDA product code HEC covers "Insufflator, Vaginal", a Class I medical device regulated under 21 CFR 884.5920. Submissions are reviewed by the Obstetrics/Gynecology panel.

Classification Details

Product Code
HEC
Device Class
Class I
Regulation Number
884.5920
Submission Type
Review Panel
OB
Medical Specialty
Obstetrics/Gynecology
Implant
No