DeviceClearance

Product code HEB— Obstetrics/Gynecology

UNSCENTED MENSTRUAL TAMPON

Classification name
Tampon, Menstrual, Unscented
Device class
Class 2
Regulation
21 CFR 884.5470
Advisory panel
Obstetrics/Gynecology
Total cleared
189
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code HEB under 21 CFR 884.5470, via openFDA

Market context for product code HEB

FDA has cleared 189 devices under product code HEB between 1978 and 2026, filed by 60 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 HEB

Adverse events under product code HEB

product code HEB
Injury
329
Malfunction
5,647
Total
5,976

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code HEB

1–100 of 189

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