SANDRO Dual
by Wontech Co., Ltd 2 variants
510(k) K252877
SANDRO Dual is a Class II device made by Wontech Co., Ltd, cleared under FDA 510(k) K252877 on 19 Dec 2025, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK252877 | Date19 Dec 2025 | StatusActive |
Official records
- FDA 510(k) database K252877
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GEX
- FDA applicant
- Wontech Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K252877
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SANDRO Dual | SANDRO Dual | 08800022304108 | — | On the market |
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