DeviceClearance

Product code HIL— Obstetrics/Gynecology

ASSURE NATURAL FIT TAMPON

Classification name
Tampon, Menstrual, Scented, Scented-Deodorized
Device class
Class 2
Regulation
21 CFR 884.5460
Advisory panel
Obstetrics/Gynecology
Total cleared
84
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code HIL under 21 CFR 884.5460, via openFDA

Market context for product code HIL

FDA has cleared 84 devices under product code HIL between 1976 and 2014, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code HIL

Recent clearances under product code HIL

Data sourced from openFDA. This site is unofficial and independent of the FDA.