Acteon Tip BS2L M+ Sterile
by Satelec
Acteon Tip BS2L M+ Sterile (F87983) is a Class II device made by Satelec, cleared under FDA 510(k) K163610 on 19 May 2017 and listed in FDA GUDID since 23 Dec 2019 (UDI-DI 03609820879833), 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 | Number03609820879833 | Date23 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK163610 | Date19 May 2017 | StatusActive |
Official records
- AccessGUDID record 03609820879833
- FDA 510(k) database K163610
Across registries
- FDA 510(k) K163610 decided 19 May 2017 Active
- FDA GUDID UDI-DI 03609820879833 listed 23 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K163610
- Listed FDA GUDID 03609820879833
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acteon
- Generic name
- Hard/soft-tissue ultrasonic surgical system
- Model / Ref / Catalog
- TIP BS2L M+ STERILE, F87983
- Primary DI / UDI-DI
- 03609820879833
- 510(k) Number
- FDA product code
- JDX
- GMDN term
- Hard/soft-tissue ultrasonic surgical system
- Device class
- Class II
- Regulation number
- 888.4580
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Hard/soft-tissue ultrasonic surgical system.