← FDA DEVICE PRODUCT CODES
FDA PRODUCT CODE · CLASS II
HEB — Tampon, Menstrual, Unscented
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.
DEVICE CLASS
Class II
REGULATION
21 CFR 884.5470
MEDICAL SPECIALTY
Obstetrics/Gynecology
REVIEW PANEL
OB
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
7
510(K)/PMA CLEARANCES
510k: 7
0
RECALL ENTRIES
Recent clearances
K252005Liviwell, Inc. · 510k2026-03-20
K253719Unibeauty (Hubei) Technology Co., Ltd. · 510k2025-12-17
K252939Cotton High Tech S.L. · 510k2025-10-09
K252613Unibeauty (Hubei) Technology Co., Ltd. · 510k2025-09-19
K251033Unibeauty (Hubei) Technology Co., Ltd. · 510k2025-08-13
K242105Essity Higiene Y Salud Mexico. S.A. DE C.V. · 510k2025-04-01
K241064Shandong Intco Hygiene Products Co., Ltd. · 510k2025-01-10
Related on SPEQ
Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.