Tampon, Menstrual, Scented, Scented-Deodorized

HIL · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.5460

Classification

FDA Product Code: HIL
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 884.5460
Review panel: OB
Medical specialty: Obstetrics/Gynecology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

A scented or scented-deodorized 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.

Market data

Cleared 510(k) submissions: 84
Registered establishments: 27

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown