FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
K Number: K252939
·
Decision Oct 9, 2025
Classifications
1
FEI Numbers
92
Registration Numbers
93
Same Product Code
188
Applicant Total
7
Review Days
24
Basic Information
- Device Name
- COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS
- K Number
- K252939
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 884.5470
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cotton High Tech S.L.
- Date Received
- September 15, 2025
- Decision Date
- October 9, 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 |
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Other Clearances by Cotton High Tech S.L.
| K Number | Device Name | ||
|---|---|---|---|
| K220238 | Cohitech Cottonlock Tampons with Reusable Applicator | Feb 25, 2022 | Substantially Equivalent |
| K211775 | Cohitech Organic Cotton Non-Applicator Cottonlock Tampons | Oct 22, 2021 | Substantially Equivalent |
| K212479 | Cohitech Reusable Tampon Applicator | Oct 8, 2021 | Substantially Equivalent |
| K182813 | COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT | Mar 15, 2019 | Substantially Equivalent |
| K152284 | COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS | Dec 4, 2015 | Substantially Equivalent |
| K091084 | MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS | Apr 29, 2009 | Substantially Equivalent |