Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
FDA 510(k) K240708 · Suzhou Borage Medical Technology Co., Ltd.
510(k) numberK240708
Submission
- Device name
- Organic Cotton Tampon; Organic Cotton PESCVcord Tampon
- Applicant
- Suzhou Borage Medical Technology Co., Ltd.
Suzhou, CN - Received
- March 15, 2024
- Decision date
- May 10, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEB – Tampon, Menstrual, Unscented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.5470
- Specialty
- Obstetrics/Gynecology
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.
Other 510(k)s with product code HEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252005 | Livi DeviceHEB · Traditional | Liviwell, Inc. | 03/20/2026SE |
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 12/17/2025SE |
| K252939 | Cohitech Organic Cotton Compact Applicator TamponsHEB · Special | Cotton High Tech S.L. | 10/09/2025SE |
| K252613 | Unscented menstrual three-piece applicator tamponHEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 09/19/2025SE |
| K251033 | Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…HEB · Special | Unibeauty (Hubei) Technology Co., Ltd. | 08/13/2025SE |
| K242105 | SABA TamponsHEB · Traditional | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 04/01/2025SE |
| K241064 | Unscented TamponHEB · Traditional | Shandong Intco Hygiene Products Co., Ltd. | 01/10/2025SE |
| K232060 | TOSAMA Reusable ApplicatorHEB · Traditional | Tosama, D.O.O. | 04/12/2024SE |
| K232598 | Unscented Menstrual TamponHEB · Traditional | Unibeauty (Hubei) Technology Co., Ltd. | 12/15/2023SE |
| K223883 | Daye TamponHEB · Traditional | Annes Daye, Ltd. | 08/18/2023SE |
More from Annes Daye, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K222046 | Unscented Menstrual TamponHEB · Traditional | 09/30/2022SE |
Questions and answers
When was Organic Cotton Tampon; Organic Cotton PESCVcord Tampon cleared by the FDA?
Organic Cotton Tampon; Organic Cotton PESCVcord Tampon (K240708) received a 510(k) decision of Substantially Equivalent on May 10, 2024, 56 days after the submission was received.
What is the product code of K240708?
The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.