Smtp XDF02806523
by SMTP Medical Co., Ltd. 3 variants
Smtp XDF02806523 is a Class II device made by SMTP Medical Co., Ltd., cleared under FDA 510(k) K201274 on 19 Feb 2021 and listed in FDA GUDID since 21 Jun 2024 (UDI-DI 06972603519231), 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 | GUDID listing | Number06972603519231 | Date21 Jun 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201274 | Date19 Feb 2021 | StatusActive |
Official records
- AccessGUDID record 06972603519231
- FDA 510(k) database K201274
Across registries
- FDA 510(k) K201274 decided 19 Feb 2021 Active
- FDA GUDID UDI-DI 06972603519231 listed 21 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K201274
- Listed FDA GUDID 06972603519231
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Smtp
- Generic name
- Hard-tissue ultrasonic surgical system handpiece tip
- Model / reference
- XDF02806523
- Primary DI / UDI-DI
- 06972603519231
- FDA product code
- JDX
- GMDN term
- Hard-tissue ultrasonic surgical system handpiece tip
- Device class
- Class II
- Regulation number
- 888.4580
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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