HEB · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5470
Classification
FDA Product Code
HEB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 884.5470
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.