MediMax Tech SPST-SL
MediMax Tech SPST-SL is a Class II device made by Medimax Tech Inc., cleared under FDA 510(k) K143103 on 16 Jul 2015 (1 earlier submission) and listed in FDA GUDID since 2 Dec 2019 (UDI-DI 00817325023719), 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 | Number00817325023719 | Date2 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK143103 | Date16 Jul 2015 | StatusActive |
Official records
- AccessGUDID record 00817325023719
- FDA 510(k) database K143103
- FDA 510(k) database K092732
Across registries
- FDA 510(k) K143103 decided 16 Jul 2015 Active
- FDA GUDID UDI-DI 00817325023719 listed 2 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K092732
- Cleared FDA 510(k) K143103
- Listed FDA GUDID 00817325023719
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- MediMax Tech
- Generic name
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
- Model / reference
- SPST-SL
- Primary DI / UDI-DI
- 00817325023719
- FDA product code
- GEI
- GMDN term
- Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
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