COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
FDA 510(k) clearance K152284 · decided 2015-12-04
Clearance details
- K-number
- K152284
- Device name
- COHITECH NON APPLICATOR ORGANIC COTTON TAMPONS;COHITECH COMPACT APPLICATOR ORGANIC COTTON TAMPONS
- Applicant
- Cotton High Tech S.L.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-12
- Decision date
- 2015-12-04
- Days to decision
- 114 days
- Clearance type
- Traditional
- Product code
- HEB
- Device class
- 2
- Regulation number
- 884.5470
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Barcelona, ES
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Livi Device (K252005) | Liviwell, Inc. | 2026-03-20 |
| Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons (K253719) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-12-17 |
| COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS (K252939) | Cotton High Tech S.L. | 2025-10-09 |
| Unscented menstrual three-piece applicator tampon (K252613) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-09-19 |
| Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital Tampons (K251033) | Unibeauty (Hubei) Technology Co., Ltd. | 2025-08-13 |
| SABA Tampons (K242105) | Essity Higiene Y Salud Mexico. S.A. DE C.V. | 2025-04-01 |
| Unscented Tampon (K241064) | Shandong Intco Hygiene Products Co., Ltd. | 2025-01-10 |
| Organic Cotton Tampon; Organic Cotton PESCVcord Tampon (K240708) | Suzhou Borage Medical Technology Co., Ltd. | 2024-05-10 |
| TOSAMA Reusable Applicator (K232060) | Tosama, D.O.O. | 2024-04-12 |
| Unscented Menstrual Tampon (K232598) | Unibeauty (Hubei) Technology Co., Ltd. | 2023-12-15 |
| Daye Tampon (K223883) | Annes Daye, Ltd. | 2023-08-18 |
| Organic cotton tampon, Viscose tampon (K231341) | Zhejiang Tianqing Manufacturing Technology Group Co., Ltd. | 2023-08-14 |
Recalls involving this device
No recalls on record reference this clearance.