SonaStar CFSM6-H185
by Misonix, LLC
SonaStar CFSM6-H185 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 00841626100176), 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 | Number00841626100176 | Date24 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK062471 | Date26 Oct 2006 | StatusActive |
Official records
- AccessGUDID record 00841626100176
- FDA 510(k) database K062471
Across registries
- FDA 510(k) K062471 decided 26 Oct 2006 Active
- FDA GUDID UDI-DI 00841626100176 listed 24 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K062471
- Listed FDA GUDID 00841626100176
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- SonaStar
- Generic name
- Ultrasonic surgical system handpiece cooling sleeve
- Model / reference
- CFSM6-H185
- Primary DI / UDI-DI
- 00841626100176
- 510(k) Number
- FDA product code
- GEI, LFL
- GMDN term
- Ultrasonic surgical system handpiece cooling sleeve
- Device class
- Class II
- Regulation number
- 878.4400
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
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