FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
K Number: K251033
·
Decision Aug 13, 2025
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
4
Review Days
132
Basic Information
- Device Name
- Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons
- K Number
- K251033
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Unibeauty (Hubei) Technology Co., Ltd.
- Date Received
- April 3, 2025
- Decision Date
- August 13, 2025
- Product Code
- HEB
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HEB | Tampon, Menstrual, Unscented | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HEB), ordered by most recent decision date.
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Other Clearances by Unibeauty (Hubei) Technology Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K253719 | Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons | Dec 17, 2025 | Substantially Equivalent |
| K252613 | Unscented menstrual three-piece applicator tampon | Sep 19, 2025 | Substantially Equivalent |
| K232598 | Unscented Menstrual Tampon | Dec 15, 2023 | Substantially Equivalent |