Tampax Satin Tampons, Closed End Flushable Applicator; Tampax Tampons, Open End Flushable Applicator
FDA 510(k) K002096 · Procter & Gamble Co.
510(k) numberK002096
Submission
- Device name
- Tampax Satin Tampons, Closed End Flushable Applicator; Tampax Tampons, Open End Flushable Applicator
- Applicant
- Procter & Gamble Co.
Cincinnati, OH, US - Received
- July 11, 2000
- Decision date
- September 8, 2000
- 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 |
| K240708 | Organic Cotton Tampon; Organic Cotton PESCVcord TamponHEB · Traditional | Suzhou Borage Medical Technology Co., Ltd. | 05/10/2024SE |
| 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 |
More from Unibeauty (Hubei) Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K203567 | Oral-B Dry Mouth Oral RinseLFD · Traditional | 04/05/2021SE |
| K201277 | Oral-B Dry Mouth Oral RinseLFD · Traditional | 09/02/2020SE |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program KitJEQ · Traditional | 08/27/2020SE |
| K151413 | Always/Tampax bladder supportsHHW · Traditional | 12/18/2015SE |
| K141018 | Oral-B Test Drive Power Brush Trial Program Kit, Oral-B Test Drive Power Toothbrush Kit…JEQ · Traditional | 09/15/2014SE |
| K133244 | Tampax M Plastic Tampons, UnscentedHEB · Special | 01/09/2014SE |
| K131543 | Tampax(R) L Plastic Tampons, UnscentedHEB · Special | 06/20/2013SE |
| K113699 | Tampax(R) V Plastic Applicator Tampons, UnscentedHEB · Special | 01/12/2012SE |
| K110669 | Tampax C Plastic Tampons, UnscentedHEB · Special | 06/02/2011SE |
| K091281 | Tampax Pearl Unscented Tampons, Light, Regular, Super & Super Plus, Tampax Pearl…HEB · Traditional | 06/01/2010SE |
Questions and answers
When was Tampax Satin Tampons, Closed End Flushable Applicator; Tampax Tampons, Open End Flushable Applicator cleared by the FDA?
Tampax Satin Tampons, Closed End Flushable Applicator; Tampax Tampons, Open End Flushable Applicator (K002096) received a 510(k) decision of Substantially Equivalent on September 8, 2000, 59 days after the submission was received.
What is the product code of K002096?
The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.