HEB — Tampon, Menstrual, Unscented Class II
Classification Details
- Product Code
- HEB
- Device Class
- Class II
- Regulation Number
- 884.5470
- Submission Type
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253719 | unibeauty (hubei) technology co | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applic | December 17, 2025 |
| K252939 | cotton high tech s.l | COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS | October 9, 2025 |
| K252613 | unibeauty (hubei) technology co | Unscented menstrual three-piece applicator tampon | September 19, 2025 |
| K251033 | unibeauty (hubei) technology co | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicat | August 13, 2025 |
| K242105 | essity higiene y salud mexico. s.a. de c.v | SABA Tampons | April 1, 2025 |
| K241064 | shandong intco hygiene products co | Unscented Tampon | January 10, 2025 |
| K240708 | suzhou borage medical technology co | Organic Cotton Tampon; Organic Cotton PESCVcord Tampon | May 10, 2024 |
| K232060 | tosama | TOSAMA Reusable Applicator | April 12, 2024 |
| K232598 | unibeauty (hubei) technology co | Unscented Menstrual Tampon | December 15, 2023 |
| K223883 | annes daye | Daye Tampon | August 18, 2023 |
| K231341 | zhejiang tianqing manufacturing technology group co | Organic cotton tampon, Viscose tampon | August 14, 2023 |
| K230419 | tampro | Sequel Tampon with Plastic Applicator | August 3, 2023 |
| K223749 | kimberly-clark corporation | U by Kotex® Click® Unscented Menstrual Tampons | January 6, 2023 |
| K222046 | suzhou borage medical technology co | Unscented Menstrual Tampon | September 30, 2022 |
| K212277 | dong-a pharmaceutical co | Tempo Tampon | April 21, 2022 |
| K220238 | cotton high tech s.l | Cohitech Cottonlock Tampons with Reusable Applicator | February 25, 2022 |
| K211775 | cotton high tech s.l | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | October 22, 2021 |
| K212479 | cotton high tech s.l | Cohitech Reusable Tampon Applicator | October 8, 2021 |
| K212272 | dong-a pharmaceutical co | Tempo Natural Tampon | September 17, 2021 |
| K212304 | calla lily personal care | Callaly Tampliner (super plus absorbency) | August 19, 2021 |