SonaStar MXA-S004
by Misonix, LLC
SonaStar MXA-S004 is a Class II device made by Misonix, LLC, cleared under FDA 510(k) K062471 on 26 Oct 2006 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00841626100510), 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 | Number00841626100510 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK062471 | Date26 Oct 2006 | StatusActive |
Official records
- AccessGUDID record 00841626100510
- FDA 510(k) database K062471
Across registries
- FDA 510(k) K062471 decided 26 Oct 2006 Active
- FDA GUDID UDI-DI 00841626100510 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K062471
- Listed FDA GUDID 00841626100510
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SonaStar
- Generic name
- Soft-tissue ultrasonic surgical system handpiece tip, single-use
- Model / reference
- MXA-S004
- Primary DI / UDI-DI
- 00841626100510
- 510(k) Number
- FDA product code
- GEI, LFL
- GMDN term
- Soft-tissue ultrasonic surgical system handpiece tip, single-use
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Soft-tissue ultrasonic surgical system handpiece tip, single-use.