Acteon 03.000.400.05S
by Satelec
Acteon 03.000.400.05S (F59935) is a Class II device made by Satelec, cleared under FDA 510(k) K100410 on 28 Apr 2010 and listed in FDA GUDID since 17 Jan 2025 (UDI-DI 03609820599359), 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 | Number03609820599359 | Date17 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK100410 | Date28 Apr 2010 | StatusActive |
Official records
- AccessGUDID record 03609820599359
- FDA 510(k) database K100410
Across registries
- FDA 510(k) K100410 decided 28 Apr 2010 Active
- FDA GUDID UDI-DI 03609820599359 listed 17 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K100410
- Listed FDA GUDID 03609820599359
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Acteon
- Generic name
- Surgical irrigation tubing set, single-use
- Model / Ref / Catalog
- 03.000.400.05S, F59935
- Description
- Irrigation set for ultrasonic surgical system Alternative DI : 20887587009664
- Primary DI / UDI-DI
- 03609820599359
- 510(k) Number
- FDA product code
- JDX
- GMDN term
- Surgical irrigation tubing set, single-use
- Device class
- Class II
- Regulation number
- 888.4580
- GUDID distribution status
- In Commercial Distribution
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