Product code HEB
- Device name
- Tampon, Menstrual, Unscented
- Medical specialty
- Obstetrics/Gynecology
- Device class
- 2
- Regulation number
- 884.5470
- Review panel
- OB
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- 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.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252005 | Livi Device | Liviwell, Inc. | 2026-03-20 |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | 2025-12-17 |
| K252939 | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | Cotton High Tech S.L. | 2025-10-09 |
| K252613 | Unscented menstrual three-piece applicator tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2025-09-19 |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons | Unibeauty (Hubei) Technology Co., Ltd. | 2025-08-13 |
| K242105 | SABA Tampons | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 2025-04-01 |
| K241064 | Unscented Tampon | Shandong Intco Hygiene Products Co., Ltd. | 2025-01-10 |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2024-05-10 |
| K232060 | TOSAMA Reusable Applicator | Tosama, D.O.O. | 2024-04-12 |
| K232598 | Unscented Menstrual Tampon | Unibeauty (Hubei) Technology Co., Ltd. | 2023-12-15 |
| K223883 | Daye Tampon | Annes Daye, Ltd. | 2023-08-18 |
| K231341 | Organic cotton tampon, Viscose tampon | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023-08-14 |
| K230419 | Sequel Tampon with Plastic Applicator | Tampro, Inc. | 2023-08-03 |
| K223749 | U by Kotex® Click® Unscented Menstrual Tampons | Kimberly-Clark Corporation | 2023-01-06 |
| K222046 | Unscented Menstrual Tampon | Suzhou Borage Medical Technology Co., Ltd. | 2022-09-30 |
| K212277 | Tempo Tampon | Dong-A Pharmaceutical Co., Ltd. | 2022-04-21 |
| K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Cotton High Tech S.L. | 2022-02-25 |
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Cotton High Tech S.L. | 2021-10-22 |
| K212479 | Cohitech Reusable Tampon Applicator | Cotton High Tech S.L. | 2021-10-08 |
| K212272 | Tempo Natural Tampon | Dong-A Pharmaceutical Co., Ltd. | 2021-09-17 |
| K212304 | Callaly Tampliner (super plus absorbency) | Calla Lily Personal Care, Ltd. | 2021-08-19 |
| K211519 | Every Cycle Reusable Tampon Applicator | Cycle, LLC | 2021-08-13 |
| K211469 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | 2021-06-10 |
| K201003 | Callaly Tampliner | Calla Lily Personal Care, Ltd. | 2020-12-07 |
| K192557 | Youjia Unscented Tampon with Plastic Applicators | Qingdao Youjia Hygiene Technology Co., Ltd. | 2020-02-13 |
| K191666 | Unscented W long plastic and cardboard applicator tampons | Ontex Bvba | 2019-12-20 |
| K191431 | Interlude Rolled Tampons in Plastic Applicator | Albaad Fem | 2019-10-07 |
| K182142 | FEMME Applicator Tampon | Jiangsu Yoai Technology Co., Ltd. | 2019-08-28 |
| K182817 | CottonDay Tampon | Taebong Co., Ltd. | 2019-07-22 |
| K182814 | Rael Tampon | Rael, Inc. | 2019-07-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195893724130 | Organic Super Tampons-8ct | TPC Inc. | 2026-05-28 |
| 00860015263445 | Organic Super Plus Tampons-36ct | TPC Inc. | 2026-05-28 |
| 00860015263414 | Organic Multi Light Regular and Super Tampons-36ct | TPC Inc. | 2026-05-28 |
| 00860015263407 | Organic Multi Super and Super Plus Tampons-36ct | TPC Inc. | 2026-05-28 |
| 00860014539992 | Organic Multi Regular and Super Tampons-36ct | TPC Inc. | 2026-05-28 |
| 00860014539985 | Organic Super Tampons-36ct | TPC Inc. | 2026-05-28 |
| 00860014539978 | Organic Regular Tampons-36ct | TPC Inc. | 2026-05-28 |
| 00860014539961 | Organic Light Tampons-36ct | TPC Inc. | 2026-05-28 |
| 00860014539916 | Organic Multi Light Regular and Super Tampons-16ct | TPC Inc. | 2026-05-28 |
| 00860014539909 | Organic Multi Super and Super Plus Tampons-16ct | TPC Inc. | 2026-05-28 |
| 00860013110963 | Organic Super Tampons-24ct | TPC Inc. | 2026-05-28 |
| 00860013110956 | Organic Light Tampons-24ct | TPC Inc. | 2026-05-28 |
| 00860013110925 | Organic Super Tampons-16ct | TPC Inc. | 2026-05-28 |
| 00195893628032 | Organic Light Tampons-8ct | TPC Inc. | 2026-05-28 |
| 00195893932832 | Organic Regular Tampons-8ct | TPC Inc. | 2026-05-28 |
| 00196852297061 | Organic Light Tampons-16ct Original Packaging | TPC Inc. | 2026-05-28 |
| 00196852637379 | Organic Super Tampons-16ct Original Packaging | TPC Inc. | 2026-05-28 |
| 00196852929245 | Organic Regular Tampons-16ct Original Packaging | TPC Inc. | 2026-05-28 |
| 00860010723173 | Organic Regular Tampons-550ct | TPC Inc. | 2026-05-28 |
| 00860012610303 | Organic Regular and Super Tampons-16ct | TPC Inc. | 2026-05-28 |
| 00860012610310 | Organic Regular Tampons-16ct | TPC Inc. | 2026-05-28 |
| 00860013110932 | Organic Light Tampons-16ct | TPC Inc. | 2026-05-28 |
| 00860012610389 | Organic Regular Tampons-24ct | TPC Inc. | 2026-05-14 |
| 00860012610372 | Organic Multi Regular and Super Tampons-24ct | TPC Inc. | 2026-05-13 |
| 08016867007221 | EARTH FARE | CORMAN SPA | 2017-02-23 |
| 08016867007238 | EARTH FARE | CORMAN SPA | 2017-02-23 |
| 08016867007245 | EARTH FARE | CORMAN SPA | 2017-02-23 |
| 08016867006828 | THE HONEST COMPANY Inc | CORMAN SPA | 2016-09-21 |
| 08016867006835 | THE HONEST COMPANY Inc | CORMAN SPA | 2016-09-21 |
| 08016867006842 | THE HONEST COMPANY Inc | CORMAN SPA | 2016-09-21 |